• Product line support for New Products Introduction (NPI) area and maintaining the assigned areas to the requirements of ISO 13485 and the FDA 21 CFR Part 820, as well as maintaining the compliance of our product to the Medical Device Directive. Areas of responsibility include but are not limited to Non-Conforming Product review and disposition, Change Control, Complaints, Risk Management, Sterile Product Release and management of corrective actions in own areas of responsibility.
• The Candidate will be responsible for design assurance activities including supporting the execution of validation and other NPI projects, assessing specifications and design reviews identifying the key quality process steps, specification and assessments needed to meet the Customer needs.
• The candidate will also be responsible for analysis and reporting of quality data, identifying and leading/supporting projects to deliver on Process Improvements which will deliver an improvement to quality, efficiency, and reduce costs. This will be complemented by strong technical aptitude with good organizational, communication, influencing, analytical, and excellent problem solving skills.
• The candidate will also be responsible for identifying areas for improvement and corrective action and leading improvement initiatives. They will achieve this through the company’s CAPA and continuous improvement systems including investigation, trouble shooting and reporting on system failures and product defects, driving effective determination of root cause and championing a structured approach to problem solving.
• The successful candidate will be an energetic individual, well organized, self-motivated with the ability to work with cross-functional teams and motivate others.
• Responsibilities include maintaining records in accordance with the quality system requirements to meet the requirements of end users, customers, regulatory authorities and the company. It will also specifically include review of batch records, approval to release product and monitoring of in process and final product and process data and trends.

• The successful candidate should have primary degree in Quality Management.
• Engineering, or Science, with a minimum of 3 years of medical device/pharmaceutical/diagnostics experience, preferably in a dynamic manufacturing environment.
• Strong, structured problem solving ability, 6 sigma and experience in a medical device assembly environment would be a distinct advantage.

• Product line support for catheter and component assembly area and maintaining the assigned areas to the requirements of ISO 13485 and the FDA 21 CFR Part 820, as well as maintaining the compliance of our product to the Medical Device Directive. Areas of responsibility include but are not limited to Non-Conforming Product review and disposition, Change Control, Complaints, Risk Management, Sterile Product Release and management of corrective actions in own areas of responsibility.
• The candidate will also be responsible for analysis and reporting of quality data, identifying and leading/supporting projects to deliver on Process Improvements which will deliver an improvement to quality, efficiency, and reduce costs. This will be complemented by strong technical aptitude with good organizational, communication, influencing, analytical, and excellent problem solving skills.
• The candidate will also be responsible for identifying areas for improvement and corrective action and leading improvement initiatives. They will achieve this through the company’s CAPA and continuous improvement systems including investigation, trouble shooting and reporting on system failures and product defects, driving effective determination of root cause and championing a structured approach to problem solving.
• The successful candidate will be an energetic individual, well organized, self-motivated with the ability to work with cross-functional teams and motivate others.
• Responsibilities include maintaining records in accordance with the quality system requirements to meet the requirements of end users, customers, regulatory authorities and the company. It will also specifically include review of batch records, approval to release product and monitoring of in process and final product and process data and trends.

• Creating additional functionality and maintaining the HR IS system
• Manage data, procedures and/or processes related to one or more of the following systems: Payroll, Employee Data, Compensation, Benefits, Learning and Development and/or Recruitment
• Co-ordinate, organise and/or lead administrative tasks in support of HR programs and initiatives; may assist professional and technical staff with special projects
• Provide data and information to others on HR area processes and procedures; may be responsible for preparing internal HR communications and/or HR intranet maintenance
• Gather and prepare data in preparation of HR initiatives and programs to include the creation of files/documents in Excel, Word and Powerpoint
• Provide reports and run queries on Peoplesoft; be the expert in this system for reporting and data manipulation; provide training to HR employees
• Regularly co-ordinate data validation on Peoplesoft
• Liaise with Compensation and benefits to provide reporting and analysis of reward and recognition usage across the site
• Develop and co-ordinate a comprehensive records retention approach to storage and access to employee files
• Be the point of contact for all queries on HR Metrics data management
• Manage the Reference Checking Data and process for leavers
• Co-ordinate the Exit Interview Process and reporting for the site
• Liaise with Compensation and Benefits on administration of Christmas Vouchers
• Co-ordinate training sessions for regular training around PADR, CMS, Stock Option Grant etc
• Support audit and compliance activity in areas of record retention and terminations process
• Perform general administrative duties which may include: meeting management, training scheduling and co-ordination, travel arrangements, calendar management, supply maintenance and mail distribution
• Perform general clerical duties to include photocopying, faxing, mailing and filing

• 3 years of HR admin experience with a minimum of a diploma in a HR/ business related discipline
• Experience maintaining HR IS systems
• A Degree would be a distinct advantage

• Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
• Perform product defect analysis.
• Routine final functional testing, product release criteria testing/inspection and recording of test results.
• Review and update of QA Documentation.
• Control of non-conforming product.
• Problem solving and continuous improvement investigations.
• Perform internal and plant wide audits as required
• Review and update of QA Documentation.
• To provide assistance and support to the Quality Engineering and Operations function.
• Provision of excellent service to all internal customers for the production group or functional area in which they work.
• Decision making ability coupled with the ability to work on one?s own initiative and with minimum supervision is required.
• Good interpersonal skills and organisational skills.
• Excellent attention to detail.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.

• Third level qualification (FETAC 6) in Quality / Materials / Science / Mechanical or Instrumentation is required.
• Strong team member with the ability to identify and drive continuous improvements.
• Excellent interpersonal and communication skills with good leadership abilities.
• Self-driven and motivation essential.
• Knowledge of GMP regulated environment and experience in a similar role would be an advantage.

• To maintain automation equipment in excellent condition ensuring consistent quality, output and yield.
• Carry out preventative and corrective maintenance, completing all associated paperwork and records.
• Follow systematic root cause problem solving and troubleshooting to resolve issues.
• Manage yield on an hour by hour basis and analyze trends and identify opportunities for improvement.
• Dealing with Pneumatics, Electronics, Hydraulics, Programmable Controllers, Servo Motor drives, Vision systems, & workshop machining.
• Managing electrical and mechanical instrumentation.
• Review of DVT images and interrogate failed images.

• 4-5 years previous hands on experience in high volume automation industry.
• Engineering Diploma, Relevant Trade Certificate.
• DVT / Vision system knowledge.
• Robotics knowledge required and root cause potential issues.
• Problem Solving ? Formal problem solving is desirable (yellow belt); if not strong mechanical problem solving skills essential.
• Yield Management.
• Microsoft office proficient ? Able to analyze data in Excel and draw logical conclusions.
• Laser Knowledge ? Have an understanding of laser operation - previous experience desirable.
• Communication skills essential- ability to explain an issue and communicated the path forward toward resolution.
• Team work - Ability to work with PB?s & as part of a core team.

• Effective and efficient management of day to day activities.
• Maintenance Management programme utilizing preventative maintenance techniques.
• Supervision of Facilities Contractors specialist and in house
• Waste Management
• Management of external contractors such as Sprinkler, Building, Electrical and Mechanical.
• Working on projects, office and production equipment relocation.
• Budgeting and cost control.
• Cost Efficiencies, Resource utilisation
• Energy requirements and utilisation.
• Health & Safety Issues.
• Environmental management procedures and surveys.
• Familiarity with Autocad
• Familiarity with building contracts, service contracts and service level agreements.
• Familiarity with computerised preventive maintenance and plant/building maintenance.
• Knowledge of interior space planning.
• Knowledge of Safety file.
• Building, services and infrastructure inspections.
• Project Management, day to day low level to large capital projects
• Disaster recovery / emergency planning.
• Statutory compliance.
• Validation of Services and Process.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• A graduate of Facilities Engineering\Management or equivalent experience with a minimum of 3 years’ experience in facilities engineering position.
• Gives technical guidance to Associate Engineers and facilities technicians.
• Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.

• Act as Senior HR Generalist to the site providing HR solutions to the business in line with our client’s Vision, Mission, values and behaviours.
• Manage internal and external recruitment processes for different categories of employees across designated areas of the business from job analysis, interviewing, referencing and management of contractual offer and acceptance and run assessment centres where appropriate. Perform Induction as needed.
• Work closely with the HR Director and senior site management to ensure robust communication channels are maintained.
• Absenteeism Management – Support Supervisors & Managers in ensuring Absence policy is implemented consistently across the site.
• Proactively respond to employee needs and ensure that the employees are recognised and responded to quickly and effectively.
• Actively partner with and coach Managers in dealing with employee performance, conduct and absence issues and resolve any grievance issues promptly.
• Take ownership of reporting against all HR agreed metrics on a quarterly basis/monthly basis

• Degree or CIPD qualified
• Minimum 7 years experience in HR in a progressive manufacturing, multinational environment.
• Experience in dealing with Employee Relations issues.
• Previous exposure to HR Best Practice.
• Excellent computer skills, including Microsoft PowerPoint, Excel and Word.
• Ability to effectively communicate & present in written and spoken English.
• Ability to successfully learn & apply new skills.
• Analytical, problem-solving skills with excellent attention to detail.
• Ability to self-manage & prioritise workload.
• Energetic and friendly disposition.
• Highly confidential.
• Ability to negotiate and influence key players on site.
• Committed, self motivated and team player.
• Remain up to date with current trends and in keeping with our client’s culture.
• Flexibility required covering HR across all shifts as necessary.

• Previous exposure to the following systems an advantage:
• ADP Enterprise
• ADP Virtual Edge
• Success Factors/ MiSuccess
• TMS

• Oversees validation of existing and new products and processes includes; IQ, OQ, PQ
• Creates and updated supporting validation documentation,
• Review, update and maintain existing validation and quality management processes and procedures,
• Participate in the design of systems and equipment to ensure that they comply with GMP requirements (PFMEA),
• Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
• Execute qualification protocols as required.
• Prepare reports,
• Attend identified training, required to fulfil the role of Validation Engineer.
• Ensure quality standards are adhered to, and all production processes are carried out according to procedures (internal auditing),
• Maintain detailed and accurate quality records, data analysis and documentation,
• Meet quality KPI’s on a timely basis,
• Investigate, communicate and ensure resolution of validation related issues,
• Ensure customers receive highest level of service, in a timely manner,
• Where necessary, escalate validation issues to management,
• Ensure all staff are fully aware and trained in matters relating to the validation process,
• Liaises with all departments in relation to validation,
• Champion continuous improvement and best practices,
• Ensure new product introductions and change controls are effectively managed in accordance with the ISO requirements when appropriate,
• Implements and advocates Corporate standard tools.
• Any other activities required for the efficient operation of the business.

• Good communication skills: written, verbal and interpersonal.
• Excellent organisational skills.
• Proactive, self-starter, who must be able to work independently without supervision.
• Good attention to detail, resulting in high level of accuracy in all aspects of the position.
• Ability to prioritise work effectively and multiple task.
• High level proficient in Word, Excel, PowerPoint, Visio.
• Positive attitude and be motivated by the role.
• Willingness to grow with the business and role.
• Exercise discretion and confidentiality as required.
• High level of professionalism and integrity.
• Operates to the highest ethical, professionalism standards.
• Ability to learn quickly.
• Willingness to be flexible and driver of change.
• Use creative approaches to achieve goals.
• Strong work ethic.

• Delivery of all key performance metrics on particular shift/project
• Provides strong, capable leadership and clear direction to all team members, including all support functions.
• Decision making at Value Stream level
• Manage and develop direct reports to achieve business goals and objectives.
• Champions effective communications across the department/shift and with the relevant Management Team members
• Demonstrates a flexible management style and is adept at utilising the appropriate style for the given situation.
• Identifies and drives continuous improvement initiatives within the department.
• Drives department adherence to regulatory and GMP requirements.
• Champion the deployment and ongoing use of Lean tools and techniques in his/ her area to identify and drive continuous improvement in order to meet all key performance metrics
• Demonstrates through his / her management style respect for the core values of our client and a commitment to teamwork.
• Promotes quality and customer satisfaction as a way of life in all department activities.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Project planning, in detail, in support of major projects, product/process transfer etc.
• The senior supervisor will work closely with the VS Manager to support the management and development of the production supervisors.
• Demonstrated ability in people motivation, organising and team building experience in a medical/pharma environment a distinct advantage
• Demonstrated knowledge and use of our clients SQP and associated Key Systems
• Advanced knowledge of and demonstrated competence in Lean tools and principles and their successful deployment to consistently meet Lean Manufacturing goals.
• Demonstrated experience in driving a compliance culture across teams
• Strong leadership skills
• Effective in driving accountability across large groups
• Demonstrated excellence in GMP / FDA regulatory requirements, housekeeping, health and safety.
• Excellent interpersonal and communication skills and ability to liaise with various support groups.
• Establish and support a work environment of continuous improvement that supports Quality policy, Quality System & the appropriate regulations for the area.
• Ensure employees are trained to do their work and their training is documented.

• Bachelor of Science Degree in Engineering, Science or Production Management is essential for this role.
• 5-8 years experience in a people management capacity in a manufacturing environment

• Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
• Perform product defect analysis.
• Routine final functional testing, product release criteria testing/inspection and recording of test results.
• Review and update of QA Documentation.
• Control of non-conforming product.
• Problem solving and continuous improvement investigations.
• Perform internal and plant wide audits as required.
• Review and update of QA Documentation.
• To provide assistance and support to the Quality Engineering and Operations function.
• Provision of excellent service to all internal customers for the production group or functional area in which they work.

Education, Experience and Skills:

• Third level qualification (FETAC 6) in Quality / Materials / Science / Mechanical or Instrumentation is required.
• Decision making ability coupled with the ability to work on one?s own initiative and with minimum supervision is required.
• Good interpersonal skills and organisational skills.
• Excellent attention to detail.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.

For further information please contact Cliona O?Malley at CCP Recruitment on 091 730022 or email cliona @ccprecruit.ie
Please Note: CCP Recruitment will not forward your details to any company without your prior approval

• Operate within Plant G.M.P regulations and guidelines at all times in accordance with EU GMP Volume 4 Part 1 and ISO13485.
•  Comply with all S.O.P’s in place relevant to your work activities.
• Comply with the requirements of the Quality Management System and relevant standards.
• Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, and production standards.
• Coordinate quality control objectives and activities to resolve production problems, maximise product reliability, and minimise cost.
• Draft and design layout of equipment, materials, and workspace to illustrate maximum efficiency, using drafting tools and computer.
• Review production schedules, engineering specifications, orders, and related information to obtain knowledge of manufacturing methods, procedures, and activities.
• Communicate with management and user personnel to develop production and design standards.
• Estimate production cost and effect of product design changes for management review, action, and control.
• Formulate sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Study operations sequence, material flow, functional statements, organisation charts, and project information to determine worker functions and responsibilities.
• Direct workers engaged in product measurement, inspection, and testing activities to ensure quality control and reliability.
• Implement methods and procedures for disposition of discrepant material and defective or damaged parts, and assess cost and responsibility.
• Evaluate precision and accuracy of production and testing equipment and engineering drawings to formulate corrective action plan.
• Analyse statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product.
• Develop manufacturing methods, labor utilisation standards, and cost analysis systems to promote efficient staff and facility utilisation.
• Recommend methods for improving utilisation of personnel, material, and utilities.
• Plan and establish sequence of operations to fabricate and assemble parts or products and to promote efficient utilisation.
• Complete production reports.
• Regulate and alter workflow schedules according to established manufacturing sequences and lead times to expedite production operations.

• Educated to degree level or equivalent within a relevant discipline. (e.g. Industrial Engineering, ).
• A recognised supervisory management qualification.
• Experience in a supervisory role preferably within a fast paced manufacturing environment.
• Computer literate especially on Excel, PowerPoint and Word.
• Six Sigma Black Belt.

• Excellent communicator with strong interpersonal and organisational skills.
• Excellent project management skills and delegation ability.
• Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.
• Ability to effectively train and develop others.
• A team builder with good strategic perspective who possess strong influencing skills.
• Ability to communicate effectively and work with colleagues and customers from diverse backgrounds and cultures.

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• test method development and validation, raw material, in process, finished product and Stability testing.
• Perform and assist with additional duties as may be directed by the QC supervisor.
• Proficient in the use various software application utilized in the laboratory.
• Create, review and approve change requests as required.
• Where required approve CR’s as laboratory trainer.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory spend and approval of vendor invoices.
• Management of laboratory inventory and supplies and ordering of same.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment calibration and qualification as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Review and approval of Laboratory results and documentation, as required the trending and charting of data.
• Manage laboratory training process and maintenance to training status.
• Provide analytical support to process validations.
• Participate on LBP/VIP and Continuous project teams as required.

• Hetac level 8 qualification in Analytical Chemistry or related discipline.
• Minimum of 2 years work experience as an Analytical Chemist within a GMP Quality Control environment in the Pharmaceutical Industry.
• Thorough knowledge of HPLC, GC, UV and FTIR .
• Thorough knowledge of Quality Systems required to support GMP Analytical Laboratory.
• Previous experience in FDA Audits an advantage.
• Excellent interpersonal and communication skills with good leadership abilities.

• Ensure the Risk Management process complies with all necessary Regulatory Standards including QSR (FDA), MDD and ISO requirements.
• Oversee the development of the Risk Management process, align and integrate with the Company’s quality management system requirements.
• Lead, manage & execute specialized projects and their designated resources as required.
• As a Subject Matter Expert, provide advice and direction to Risk Management personnel.
• Develop and conduct training programmes that will ensure the necessary application and compliance to Risk Management process requirements.
• Participate on the Risk Management Board to oversee the correct application of the process.
• Develop relevant Key Performance Indicators (KPIs) including reports and present to management as necessary.
• Develop and maintain strategic & tactical plans to meet the future business needs of the Company.
• Adhere to all Health & Safety procedures and requirements.

• Minimum of five years related experience in a manufacturing environment, preferably within the Medical Devices industry.
• A third level academic qualification in Science, Engineering or Quality discipline.
• Working knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations.
• Proven project management skills.
• Strong verbal, written, and interpersonal skills.
• Must be able lead a team in a dynamic environment and interact effectively at all levels and across all functions within the organisation.
• Ability to manage & motivate a team in attainment of stretch targets across multiple sites

• As part of the New Product Development team provide input to design tangibles and risk analysis during new product development and release.
• Prepares, reviews, analyzes and files appropriate regulatory documentation (e.g. 510ks, FDA registration and listings, regulatory assessments, product technical files to comply with European Medical Device Directive).
• Liaise with the US Regulatory personnel, manage product regulatory registration activities for all new and transferred products per project timelines.
• Assess proposed changes for regulatory implications and implementation of identified actions to maintain product registrations in impacted countries.
• Provide technical data to all locations in support of country specific product registrations and regulatory requirements.
• Co-ordinate CE Marking activities with US Regulatory personnel, including new submissions and file modifications as required.
• Investigate complaints for medical reporting and filing to the appropriate authorities if required.
• Reviews labelling and literature for regulatory concerns.
• Liaise with Notified Body and Irish Medicines Board as Competent Authority in all technical matters relating to product approvals, changes and issues.
• Represent our client with various regulatory bodies, such as Irish Medicines Board and Irish Medical Devices Association.
• Ensure compliance locally with current regulatory requirements as per our client’s Divisional and Corporate Recall and Regulatory procedures.
• Provide support to day to day product hold and recall related activities and procedures.
• Co-ordinate preparation, take participation in and complete follow up for regulatory/recall related activities and procedures for internal, Corporate and third party external regulatory compliance audits.
• Prepare quality reviews and trending activities.
• Lead & Participate in cross-plant and divisional project teams in areas of compliance and quality systems improvement.

• A Degree/Diploma in Quality Management or equivalent discipline is required.
• A minimum of 2 years experience in a Quality Assurance compliance position is required; exposure to Regulatory Agencies such as the FDA and/or Notified Bodies is desired.
• Excellent communication, organisation and time management skills with the ability to manage several priorities at once will be required as will a high level of flexibility with a high level of commitment to success.
• Strong project management capabilities.
• High level of PC skills required.

• Required to work, in an FDA / IMB approved GMP manufacturing facility, in ensuring compliance to new and established systems and global regulations and guidelines for a wide range of complex active pharmaceutical ingredients and intermediates
• Must work as part of a team with an emphasis on continual improvement of processes, quality management systems and compliance. The position requires good communication skills, organization and an eye for detail.
• Issuance, Control and Review of Production Batch Records for API batches and intermediates.
• Review/Release of all API and Intermediates as appropriate
• Preparation of SOP’s and carrying out document review/updating as appropriate
• Manage the Deviation/CAPA and Change Control Management Systems
• Participate in cross functional investigations involving RCA’s (root cause analysis investigations), advise on corrective actions and assist with their implementation.
• Participate in cross functional teams for the introduction of new products/processes, carrying out risk assessment and preparation/approval of cleaning documentation associated with these activities
• Carryout GMP training for site employees and play an active role in site quality initiatives
• Ensure all site calibrations and utilities are carried out and maintained in a compliant manner
• Participate in all aspects of audits by Regulatory Authorities and Customers
• Conduct internal audits as per agreed schedules.
• Be proficient in the use of IT based systems for document control, material resource planning (SAP), etc.
• Demonstrate a flexible approach and participation in companywide improvements plans.
• To become familiar with all aspects of the Quality Department and deputize in the absence of other Quality Assurance Specialists when requested.
• Other duties as required by the department manager, which is in keeping with the nature of the role.
• To take reasonable care for your health and safety and for others in the workplace

• B.Sc. Degree in a technical or scientific based subject – Chemistry, Biochemistry, etc.
• Minimum of 2-3 years in a QA Specialist or Compliance Role in a Regulated Pharmaceutical Industry (API and/or DP manufacture)
• Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CRF 211
• Excellent communications skills
• Flexibility is essential
• Proven ability to work on own initiative
• PC skills MS Word, Excel, PowerPoint, MS Project, etc.

• Proactively design and implement multi-channel supply chain support models to meet business needs.
• Serve as a functional expert in supply chain which includes but is not limited to channel operations, order management, material requirement, purchasing, supplier management, inbound logistics, import/export, warehousing, distribution and reverse logistics.
• Drive inventory management using entitlement levels for raw material & WIP to ensure LIFER targets are achieved.
• A key responsibility is proactive design and implementation of supply chain solutions to support growing volumes in existing channels and the addition of new channels; evaluation of and management of, an outsourced logistics model.
• Manage members of the stores, repack & logistics function, conducting appraisals in a timely manner and addressing performance issues should they occur.
• Ensure adequate training and development is provided for all members of the stores & logistics function.
• Manage all planning activity for external manufactures to ensure uninterrupted supply through external manufacturers & service providers such as sterilisation to include on-going business, product transfers and new product development.
• Provide supply chain structure and support for the management of the NPI (New Product Introduction) process
• Ensure that all activity is in compliance with GMP, ISO and FDA requirements.
• Ensure effective and timely communications weekly/monthly written reports, status updates, daily / weekly direction to management team and external stakeholders.)
• Drive process improvement teams and projects to improve logistics flow both internally and externally to the plant.
• Lead Indirect procurement activities and collaboration with sister sites in Ireland to deliver best cost and delivery for the organisation.
• Ensure that all Health, Safety and Environmental requirements are fulfilled in accordance with the responsibilities defined in the Company’s Safety Statement.
• Ensure effective and timely closure on all Corrective Action Requests and MAP items.
• Strive for highest standards in GMP and housekeeping standards.
• Ensure responsibilities under the Quality System as defined in the Quality Manual are met.
• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

• Understanding and driving customer focus within the manufacturing organisation.                    
• In depth working knowledge of mainframe manufacturing systems particularly J.D. Edwards & SAP
• Knowledge of manufacturing supply chain processes.
• Self-motivated with excellent communication skills
• Ability to build effective partnering relationships using persuading and influencing skills
• Strong organization skills and an aptitude for project planning.
• Can drive continuous process improvements.
• Ability to translate complex situations into simple working solutions
• Ability to manage people in a matrix reporting structure with an aptitude for coaching and developing leaders.
• Ability to make effective oral and written presentations which result in meeting the departmental goals/objectives
• Ability to prioritize and manage multiple projects simultaneously while meeting deadlines and budget constraints.
• Ability to provide global leadership per the Leadership Imperatives
• Ability to apply knowledge of products and customers and achieve associated business requirements.
• Ability to make sound management decisions and identify actions that will support company initiatives within the supply chain.
• Ability to apply basic project management techniques.
• Ability to drive cross-functional alignment through effective communications.

• Ideal candidate will be qualified to degree level in a technical or commercial discipline.  Additional post-graduate educational achievements are highly desirable such as MSc or MBA.
• Proven people management skills managing a team in a highly flexible manufacturing logistics environment.
• Minimum 10 years directly related Supply Chain experience within a multinational environment.
• Ability to work with Integrated Business Systems (preferably J.D.Edwards & SAP)
• Expert knowledge of shipping and freight procedures
• Ability to understand and utilise modern computerised applications & business solutions.
• Excellent knowledge of Medical Device Industry and associated regulatory requirements.
• Previous experience or working knowledge of Lean    manufacturing would be a distinct advantage
• Proven track record in leading change& change management projects within the stores & logistics area.

• Develop and maintain best in class treasury processes, procedures, systems and control environment
• Implement Cash management capability OUS
• Undertake day to day Back-Office treasury operations in line with approved treasury policies, procedures and controls
• Ensure all deals are correctly accounted for on the Treasury Management system– resolve all discrepancies
• Ensure loan repayments, interest repayments, interest rate swaps and other financial instruments are correctly settled
• Ensure all loan covenants and reporting obligations are complied with including the computation of loan covenants and the issuance of compliance certificates
• Report monthly on all Treasury activities to the Corporate Treasurer, Finance Director.
• Perform month end close for Treasury and reconciliations as required
• Assist in preparation of financial instruments section of year end financial statements, manage the external audit process and liaise with Auditors
• ImplementFAS 133 andFAS 157 (IAS 39), carry out hedge effectiveness on an ongoing basis and advise of IAS 39 implications for new treasury products as and when they arise
• Support Corporate financial planning projects
• Other duties as may be assigned from time to time

• A recognised accounting/treasury qualification with 7 to 10 yrs experience operating in a similar environment
• Experience in business banking e-trading platform, Salmon Treasury Management System and Bloomberg an advantage
• Excellent understanding of accounting standards and their application to treasury instruments
• Excellent analytical & Financial Modelling Skills
• Must be systematic and highly organised with an ability to work to tight deadlines and on own initiative
• High degree of professionalism essential at all times
• Strong written and verbal communication skills are essential.

• Generate concepts/ideas that revolve around equipment/fixture type solutions.
• Design equipment/fixtures with deliverables that are aligned with the requirements of the manufacturing process stakeholders.
• Collaborate with the Process Development Group on new product introductions on the design & sourcing of custom equipment. The key skill will be the spec’ing of equipment.
• Obtain an in-depth knowledge of our existing manufacturing processes to enable cost reduction opportunities to be identified and assessed for appropriateness.
• Generate & manage a detailed Project Plan that ensures equipment/fixture solutions are implemented into the manufacturing area in an effective & timely fashion. Successful implementation will involve building up a strong working relationship with all of the manufacturing process stakeholders.
• Work closely with our in-house Engineering Workshop in getting equipment/fixtures fabricated. Or identify a suitable external engineering fabrication shop where appropriate.
• Collaborate with external design houses to identify equipment solutions appropriate for our clients manufacturing processes.
• Seek out possible ‘off the shelf’ equipment solutions that are in line with our cost reduction goals.
• Acquire a thorough knowledge of new technologies on the market by reviewing Trade & Industry publications, attending exhibitions and interfacing with colleagues at other sites.
• Have a working knowledge of the Machinery Directive 98/37/EC (i.e. CE marking) as it pertains to machinery design, fabrication and testing.

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• Responsible for operational readiness of the manufacturing areas and processes.
• Support technology transfer
• Responsible for all activities, i.e. manufacturing, cleaning and maintenance of the manufacturing areas, equipment and processes.
• Responsible for implementing and maintaining appropriate and adequate EHS controls in all production areas.
• Coordinating, organizing and scheduling of Activities
• Responsible for assigned shift performance & resource management of production shift team
• Responsible for oversight of all operations on site activities in out of hours (i.e.activities that occur on site outside 8am – 4:30 Mon-Fri work hours)
• Employ strict applicable cleanroom techniques to all process related activities
• Support of Commissioning and Qualification activities
• Accountable for Production Batch Manufacture and Review
• Responsible for managing operations shifts to ensure that shift targets are met
• Maximising the team's performance on a team and individual basis
• Ensure process equipment maintenance, calibration and repair to ensure the least amount of downtime of production lines.
• Ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements
• Participate in regulatory audits and ensure audit readiness at all times
• Responsible for resource and performance management for all manufacturing team, i.e. manufacturing team members and process technicians.
• Generation, review and revision of Operations documentation as necessary.
• Responsible for training of manufacturing team and ensure manufacturing teams compliance with company standards.
• Maintains time and attendance (T&A) records for the manufacturing team.
• Ensure effective communication occurs within the team, between shift teams and with other departments.
• Carry out routine and non-routine tasks as required, according to appropriate procedures, values and standards.
• Working assigned shift patterns to meet business needs and Operations schedule.
• Implementing and maintenance of material, production and personnel controls
• Ensuring completion of all manufacturing documentation in compliance with site procedures and GDP.
• Responsible for completion of transactions on ERP/MES, and other systems.
• Ensure that housekeeping standards in Operations facility are maintained to a very high standard of GMP readiness.
• Establishes or adjusts work schedules to meet production requirements.
• Lead investigations and resolution of problems during manufacture.
• Participate in/lead Cross-Functional teams as necessary.
• Participate in/lead Emergency Response/Fire/First Aid teams as necessary.
• Troubleshoot process and product deviations.
• Demonstrate Credo value of integrity.

• Capable of working in a highly regulated GMP cleanroom environment.
• Ability to manage a multi-functional team
• Strong people management skills
• Strong organizational/administrative skills
• Effective communication and presentation skills in one-on-one and group situations.
• Self-directed and self-motivated.
• Proficiency in using statistical risk analysis tools, process capability analysis, technical troubleshooting, i.e. 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology.
• Excellent interpersonal skills.
• Strong problem solving skills.
• High Levels of attention to detail.
• Highly Results and performance driven.
• Change leadership skills
• Mechanical/Technical aptitude.

• Bachelor’s degree from an accredited college or university, preferably in either Biotechnology, Science or Engineering.
• 5+ years management/supervisory experience required, of which
• 2+ years management experience in an automated manufacturing environment including maintenance responsibility
• 2+ years of which in a aseptic (i.e. Grade B or higher) regulated manufacturing environment
• Experience of autoclave, parts washer and filtration processes.
• Experience of ERP, MES, SCADA and PLC systems

• Resolve and assist in the closure of Production related deviations/CAPA’s/Complaints and follow up in the Quality system as required.
• Ensure that change requests and DCRs are compliant with all applicable procedures. This will involve actively reviewing the CR’s and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers, and site management.
• QA input (review and approval) for Process Development activities eg. Characterization Studies, Optimization Studies, Test Method Validation etc.
• QA input for all production related activies.
• QA review of Batch Record documentation.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Tranfer Strategies/Plans, Procedures, Batch Record updates, Risk Assessments, SOP’s etc.)
• Ensure output of studies are incorporated to relevant commercial documentation.
• Recommend Process Improvements.
• Implement, deploy and revise as applicable procedures.
• Provide support and advice during cross functional investigations / projects and as required.
• Provide guidance to project teams on Validation strategy and approach.
• Review / Approval of Validation Protocols ( e.g. Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Review / Approval of Validation Reports ( e.g. Process, Cleaning, Test Method, and Equipment validations)  to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Develop/Review/Approve Validation Master Plans
• Conduct Staff Training (Risk Management, Verification / Validation).
• Generate SOP’s/other documentation as applicable.
• Define and Implement the Batch Release Process.
• Adherence to FDA 21 CFR Parts 600, 606,  210, 211, 820  and 11.
• May be required to work a shift system in accordance with the operational needs of the business.

• Proficiency in applicable GMP/QSR regulations.
• Ability to Troubleshoot and carry out Root cause analysis.
• Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
• Demonstrate excellent communication skills (verbal and written).
• Ability to develop and give presentations on technical and regulatory topics.
• Ability to train/mentor associates.
• Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
• Ability to read, analyze, and interpret complex technical documents and manuals
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Minimum qualification B.Sc or M.Sc/M.Eng Degree in one of the following disciplines:  Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
• QP qualification is desirable.
• 4-6 Years post educational experience working in a regulated  environment preferably within a Pharma/Biotech facility
• Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations.
• Understanding/experience with a process and utility plant start-up would be an advantage.
• Statistical Analysis  competency required.
• Good level of computer literacy required.

• Review / Approval of Validation Protocols ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Review / Approval of Validation Reports ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations)  to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Resolve and assist in the closure of discrepancies initiated during Qualification execution.
• Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the CR’s and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers, and site management.
• Develop/Review/Approve Validation Plans.
• Implement, deploy and revise as applicable Validation procedures.
• Conduct training in Validation Methodologies and related procedures as required.
• Provide guidance to project teams on Validation strategy and approach.
• Generate SOP’s/other documentation as applicable.
• Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820  and 11.
• May be required to work a shift system in accordance with the operational needs of the business.

• Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
• Demonstrate excellent communication skills (verbal and written).
• Ability to develop and give presentations on technical and regulatory topics.
• Ability to train/mentor associates.
• Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
• Ability to read, analyze, and interpret complex technical documents and manuals.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Minimum of degree qualification in relevant science and/or engineering discipline
• 3 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility.
• 4-6 yrs in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations.
• Have a strong working knowledge of statistical techniques in the use of problem solving/ data analysis.
• Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.

• Development and introduction of key site quality systems as assigned: Deviation process, CAPA Process, Management Review Process, Supplier Quality, Site Audit Readiness activities for both internal and external audits and Batch Record Review.
• SME for assigned quality systems providing ongoing guidance and direction to Associates at all levels in the organization.
• Work with a cross-functional and cross site team to develop and introduce electronic quality systems i.e. ETQ, Trackwise.
• Implement the Quality Management System.
• Resolve and assist in the closure of deviations initiated during qualification/ production and follow up in the Deviation system as required.
• Support the development and implementation of quality reporting metrics.
• Track and trend key quality indicators and issue reports. Prepares presentations for Management Review Meetings.
• Conduct self-inspections and external audits as appropriate.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans etc.)
• Update and maintain the Approved Supplier List. Approve Suppliers and materials/services as required.
• Conducts/participates in supplier audits. Works with suppliers to ensure corrective action plans are developed and implemented for non-conformances identified.
• Assess requirement for and Develop Quality Agreements/Commitments.
• Lead Supplier Review Board.
• Provide training in all aspects of Quality Management Systems and GMP.
• Provide support and advice during cross functional investigations / projects and as required.
• Drives the continuous improvement of the key Quality System processes.
• Define and Implement the Batch Release Process.
• Provide QP oversight for manufacturing, packaging, testing and release of commercial product.
• Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
• May be required to work a shift system in accordance with the operational needs of the business.

• Proficiency in applicable GMP/QSR regulations.
• Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
• Demonstrate excellent communication skills (verbal and written).
• Ability to develop and give presentations on technical and regulatory topics.
• Ability to train/mentor associates.
• Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
• Ability to read, analyze, and interpret complex technical documents and manuals
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Minimum qualification B.Sc Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
• QP qualification is essential.
• 6 Years or more post educational experience working in a regulated environment, preferably within a Pharma/Biotech facility
• Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations.
• Understanding/experience with a process and utility plant start-up would be an advantage

• Continuously assesses capability to drive strategic initiatives to improve sales excellence.
• Establishes processes, practises, standards and tools to drive adherence to our Sales Process and ensure a disciplined sales process.
• Establishes and implements appropriate standard work and sales competencies for the various roles within the Sales Force and secures effectiveness of these across EMEA
• Boosts sales effectiveness & establishes capability to derive insights from data
• Increases transparency & analytical rigour to our sales force performance to increase Sales effectivenes
• Implements best practise tool sets across the performance measurements and management aspects of the business.
• Utilises and promotes excellence in Project Management toolsets and practises.
• Utilises and promotes principles of lean continuous improvement, six sigma and business process optimisation.
• Using strong business and commercial acumen, identifies innovative, effective and efficient ways to analyse, report and feed strategic information to the business.
• Collaborate strongly with the business.
• Acts as a strong Change Agent with strong influential and communications skills.
• Acts as strong people manager and develops a high performing team, enhancing capabilities, skillsets and tools.
• Sets consistent policies with respect to field sales support activities.
• Optimizes existing processes through appropriate use of technology.
• Provides field sales management with reporting and mechanisms relative to key performance indicators of sales force performance, customer performance etc.
• Develops excellence in all aspects of Sales Operation metrics generating information which can be easily used to identify opportunities, drive growth and measure execution.
• Drives continuous improvement across Sales contests to drive increased motivation.
• Establish Centre of Excellence Skillsets and capabilities to drive appropriate business decisions and direction.
• Connects, leads and / or brings voice of customer thinking to strategic and / or corporate initiatives.
• Works closely with IT and US counterparts to ensure best, efficient and effective solutions for EMEA
• Resolving complex functional issues.
• Training users on implemented systems.

• For non-chemical purchases responsible for MRP management, review and execution of purchase requisitions and purchase orders, vendor scheduling, inventory reporting and inventory positioning.
• Responsible for developing and maintaining best practice systems and procedures, coordinating and efficiently operating all aspects of the plant’s supply chain/ logistics processes in line with corporate guidelines and procedures and best material management/ procurement practices.
• Work closely with purchasing personnel and other key departments across the Group, namely Quality Operations, Manufacturing, Technical Services, Engineering to ensure high levels of customer service.
• Work closely with corporate purchasing and supply chain to ensure close links result in the needs of the site being met, developing contingency plans where appropriate.
• Responsible for meeting budget targets in terms of performance, costs and value add.
• Measurement of product profitability and leading cost reduction projects.
• Development and reporting of KPI’s for continuous improvement.
• Manage all aspects of Inwards Processing, INTRASTAT, VAT.
• Participate in or deliver all other projects/ works as directed by the Finance/ Supply chain/ IT Director.
• Management, coordination and procurement of materials for the company, ensuring that the supply needs in time, quality and GMP compliance are met.
• To manage the quality/ price/ availability/ relationship with suppliers to ensure that site/ end user needs are met.
• Liaise with internal customers to prepare weekly production, purchasing and shipping schedules and ensure that targets are met.
• Monitor production plans/ performance weekly and realign to ensure that the purchasing strategy fully supports both production and project targets.
• Liaise with Corporate Purchasing to create procurement schedules for raw materials and packaging components. Execute the delivery of the schedules once P.O.’s have been raised by Corporate Purchasing.
• Monitor inventory levels and report any deviation from plan and implement corrective actions where applicable.
• Liaise with the site Purchasing Reps to ensure the most cost effective supplier is always used while not compromising on quality.

• Minimum 5 years’ experience in procurement and logistics management on a pharmaceutical manufacturing plant.
• 3^rd level qualification in a relevant discipline (Chemical Engineering, Supply Chain, Project Engineering/ Mechanical Engineering).
• APICS/ CIPM/ IIPMM or relevant materials management qualification an advantage.
• Excellent, interpersonal and communication skills.
• Ability to deliver in a fast paced, flexible and results focused environment
• Strong negotiation skills.
• Must have a thorough understanding of the various purchasing functions and how they effectively intertwine for efficient operation.
• Experienced with import/ export regulations including customs and excise legislation.
• Proficient in Microsoft Excel and a good understanding of other computer software packages.
• Working knowledge of SAP (MM) a distinct advantage.

• Conduct of External Audits
• Conduct of Internal Audits
• Provide Quality Training
• Oversee Change Control activities

• Customer Complaint investigation
• Problem solving / Trouble shooting

• Validation support for product, processes, packaging, and sterilization.
• Develop inspection plans and procedures
• Support NPI / Minor Mod Process requirements.

• Problem Solving
• Reliability design improvements
• Product failure trending
• Process improvement initiatives using quality tools

• Statistical process control
• Incoming part/product inspection criteria
• In-Process and Final Inspection
• Automated testing
• Functional gauging
• Productivity / Inspection reduction improvements

• Co-ordinate CAPA trending and reviews
• CAPA approval, trending and improvement identification

• Problem solving
• Vendor Auditing
• Inspection techniques/equipment
• Training

• Routine ECA Environmental monitoring and reporting
• Sterility assurance program - monitoring and validation.
• ·Has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. Also has the authority to order the recommencement of production provided he/she is satisfied that all issues pertaining to the non-conformance have been addressed.

• Excellent analytical skills.
• Effective interpersonal communications skills.
• Blueprint/Engineering schematic reading and interpretation.
• Basic inspection techniques.
• Basic PC skills.
• Must be able to generate, follow and explain detailed quality requirements and inspection procedures. Must be able to communicate product and/or component parts deficiencies to internal and external customers.
• Must be able to identify and analyze non-routine product issues
• Using independent judgment and inspection equipment.
• Must be able to plan, organize, and implement multiple concurrent tasks.
• Bachelor Degree in an Engineering or Science related discipline or equivalent experience.
• 2- 5 years related experience desirable

• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their area?s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (E.g. Use of DOE studies, FMEA?s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP?s of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

• Minimum qualification: BSC/BEng degree.
• Minimum of 2/3 years? experience in a QA role.
• Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
• Strong project management skills.
• Good level of technical and analytical expertise to assist in problem solving.
• Good knowledge of statistics would also be an advantage.
• Experience/training in problem solving methodology. (Engineering Essentials TM).

• Work as part a team to drive product and process improvements.
• Manage the product history file and ensure that all product changes are managed and kept up to date.
• Work closely with SME’s in the business to ensure all new product fit within our clients existing manufacturing capability.
• Work closely with Lean and operations teams to ensure that any new processes developed meet world class manufacturing standards.
• Manage a variable workload to meet NPI requirements.
• Design and introduce manufacturing processes for new products to meet the demands of productivity and quality.
• Ensure that complete and effective validations are carried out on all processes before transferring to manufacture.
• Identify and put in place permanent and effective technical / system solutions to problems.
• Maintain high quality / compliance standards in line with Medical Devices manufacturing requirements.
• Applying Lean principles, identify and develop improvements that increase key process metrics of yield, throughput and productivity.
• Investigate new process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Manage external relationships with Technology providers / Suppliers.
• Ensure that all Health, Safety and Environmental requirements are fulfilled

• Engineering degree, or equivalent qualification, preferably with at least 3-5 years experience.
• Strong technical background and capabilities.
• Motivated to work on own initiative and the ability to make and implement decisions.
• Knowledge of ISO and FDA compliance with emphasis on validation.
• Knowledge of six sigma and lean manufacturing principles.
• Excellent communication, planning and organisational skills.
• A demonstrated ability to solve problems with innovative and cost effective solutions.
• Computer literate.

• Act as Functional Lead for Oracle Supply Chain & Manufacturing
• Act as IT lead in Strategic Business Projects
• As an Oracle functional expert identify, define & deliver initiatives to optimise the existing Oracle 11i implementation
• At all times provide a global focus to cater for current needs and future expansion to all of our client’s sites
• Gather and document business requirements for related IT projects
• Documenting business processes
• Provide hands-on functional and configuration support.
• Mentor Support staff.

• Strong knowledge of Oracle Supply Chain & Manufacturing 11i essential.
• Experience of Oracle Supply Chain & Manufacturing R12 desirable.
• Proven experience of Purchasing, Order Management, Inventory Planning & Management, Forecasting, Bills of Materials, Routings, MRP, Production Scheduling, WIP Management, Product Costing and Quality.
• Must be capable of working in collaboration with various functions to define & delivery innovative solutions within aggressive timescales.
• Previous experience in a lead role in at least two implementations or upgrades of 11i essential.
• Upgrade and functional experience of Oracle Release 12 desirable.
• SQL / Reporting experience developing reports desirable.
• Familiarity and knowledge of accounting practices.
• Minimum of 7 years experience in related field.
• Experience in a GMP regulated manufacturing environment desirable.
• Excellent communication skills at all levels of the organisation.
• Strong project management skills to include proven experience of running small to medium sized projects.
• Strong organisation and time management skills.
• Will be required to work flexible start/finish times.
• May be required to travel to other sites as and when required.

• Identify and plan training to address gaps in both skills and behaviour. Effective escalation of any systemic performance issues not addressed by coaching and training.
• Provides leadership to the SQE Team by communicating business requirements and providing guidance towards achievement
• Set individual team member objectives through the formal Performance Management process and conduct regular 1:1 sessions, including mid-year and end of year reviews
• Manage time and attendance for the team, including leave planning.

• Ownership and reporting on all quality issues associated with suppliers within the assigned commodity.
• Lead supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products. Plan and complete Supplier Corrective Actions.
• Liaising with the Manufacturing and Quality Engineers in the Business
• Units, in assessing and addressing material quality issues.
• Track supplier quality performance measurements for suppliers (KPI’s) and participate in supplier performance reviews.
• Maintaining the Approved Supplier List (ASL) in conjunction with the Procurement function

• Lead risk assessment activities and ensure that all failure modes for supplier issues have been identified and addressed.
• Implement and develop mechanisms to monitor and identify supplier non-conformance trends
• Lead Problem Solving, Failure Analysis, Corrective Action & Preventative Action activities with the Suppliers.
• Promote a culture of structured problem solving with suppliers.
• Continuous Improvement:
• Manage and drive continuous improvement activities focusing on supplier quality.
• Identify and leverage best practices in relation to Supplier Quality Management.
• Ensure the efficient and timely transfer of process or product knowledge between our client and supplier project personnel and internal manufacturing, quality and design engineers.

• Liaise with Procurement function to develop and execute Supplier Development Programmes, specifically where quality issues have occurred due to supplier process control or non compliance.
• Align directly with Strategic Sourcing to ensure all supplier related quality issues are effectively communicated and managed to closure.

• Perform supplier quality audits and management of the supplier corrective action process
• Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required.
• Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
• Ensure compliance of QMS procedures for the associated supplier.

• Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
• Ensure all Supplier related material quality issues for the Ireland campus are effectively communicated

• Degree in Engineering, Science or equivalent is required.
• 5+ year’s relevant QA experience in GMP manufacturing environment in Medical Device industry.
• 2+ Years people management experience including effective application of a structured Performance Management Programme.
• Demonstrated experience in Quality Engineering, Quality Systems/Compliance.
• Excellent Problem Solving and analytical Skills and ability to handle multiple tasks in a fast paced environment.
• Proven people, project management and leadership skills.
• Strong verbal, written and interpersonal skills.
• Proven to be self-directed, self-motivated and able to prioritise and resolve competing priorities.
• Possess highly developed interpersonal skills.
• A working knowledge of Statistical techniques and analysis would be desirable. Green or black belt six sigma an advantage
• The individual should enjoy working in a dynamic and results motivated team environment.
• Strong project management capabilities
• Ability to plan, organize and implement multiple concurrent tasks

• The Sourcing Manager will be accountable for the following key areas:
• Identifying risk in the RM supplier base and mitigating this risk through strong project management by ensuring robust BCP’s are implemented.
• They will measure supplier performance working with the supplier quality group and pay particular attention to ensuring supplier related backorders are highlighted in advance and removed as a matter of priority. They will ensure that all backorder issues are escalated to the business in a timely manner.
• They will assist in locating and selecting suppliers per business requirements & category strategies.
• They will ensure appropriate commercial agreements are in place for each key / high risk supplier.
• They will partner with the extended Source organization where appropriate and support OGSM’s where necessary
• Cost Improvement Plan targets will apply.They will play a key role in partnering with Make and Engineering groups to identify additional savings & BCP opportunities.
• They will also contribute to wider GSC initiatives and be a proactive member of the extended Leadership team.
• Attendance at key weekly meetings, back-order & Supply review meetings
• Communicate, monitor, and aggressively manage compliance with the sourcing strategy or business process
• Partner with the Category, ASL & SEI functions to ensure alignment to meet and exceed goals
• Establish close working relationships with other functions, (e.g. Engineering, Operations, Marketing and Quality) to ensure full understanding and support of strategic sourcing perspective to key processes and address technical needs
• Establish proactive issue communication to the Make function, manage supplier partnerships & contribute positively to the efficiency of Supply Chain     
• Ensure alignment to the strategic direction provided by the Source Leadership Team
• Partner with Supplier Quality to ensure alignment on supplier management processes
• Champion annual productivity improvements by leading internal & joint supplier teams pursuing cost reduction opportunities in alignment with sourcing strategy (e.g. lowering inventory levels, increasing yields, operation improvement)
• Upgrade supplier skills (ship-to-stock, emerging technologies, etc.)
• Assist in managing supplier capabilities including but not limited to capacity planning, tooling and resource investments including inventory management
• Develop an expertise in the business needs and capabilities for major spend categories or key business processes.  Keep up with supply market trends, supplier economics, and best practice sourcing
• Analyze overall system capabilities in support of the supply chain
• Ensure training on and compliance with relevant company procedures
• Support of the Synthes integration

• Purchasing procedures & processes
• Internal & external supplier manufacturing processes
• Negotiation approaches
• Commercial & legal agreements
• Project management techniques
• Kaizen & Lean approaches

• Minimum of 3 – 5 years relevant experience in a logistics/supply chain role within a high volume manufacturing environment
• Minimum of 3 - 5 years procurement/sourcing experience preferred
• Knowledge of E2E Supply Chain
• BS Degree in Finance, Business, Engineering, Operations Management or related field
• MBA or Masters an advantage
• Analytical-absorb information & solve complex problems quickly
• Experience of people management
• MD background an advantage
• Proficient in Microsoft Office applications

• Strong leadership
• Excellent interpersonal skills required 
• Strong Stakeholder management
• Excellent written, oral, and presentation skills required
• Ability to influence/collaborate to get to desired result
• Customer focus (internal & external)      
• Adaptable to meet rapidly changing priorities
• Exercise a high degree of business judgment and sound reasoning
• Strong Credo values
• Travel Approx 30%
• Continuous improvement focus

• Project manage the development of medical device products from concept to production including acquisition integration. Participation in multifunctional product development teams and liaison with marketing for the development and specification of new concepts for medical device products.
• You will work with a highly creative design team to conceive plans for new product development invent and develop innovative new product solutions.
• Actively participate in the development process for assigned projects with focus on innovation, time to market, cost minimisation, DFM (Design for manufacture) and in-built product quality.
• Develop and implement project budgets. Optimize R&D return on investment, undertake cost benefit and breakeven analysis of proposed new product ventures including both process and product development. Compilation and review of annual and monthly R&D project budgets and monthly spend projections.
• Compiles project plans for assigned projects and coordinates project team meetings. Communicates regular updates on project status to divisional R&D and AO leadership and project sponsors. Coordinates with business units, advanced operations, suppliers and functional leaders as needed to ensure specific cost, time and/or regulatory standards are met. Communicates regular updates on project status to senior management, the project team, stakeholders and sponsors.
• Will monitor and control progress of projects to provide technical oversight and ensure sound application of engineering principles are used and design intent of new technology is being followed/achieved through product commercialisation.
• Partner with the strategic sourcing and advanced operations to develop close strategic collaboration’s with external development partners, equipment and component suppliers, Original Equipment Manufacturers (OEM’s) and technology partners to ensure appropriate vendor selection and optimum supply chain design.
• Work closely with Advanced Development, Product Development and Advanced Operations on product design, design for X (manufacturability, assembly, inspection etc), tolerance analysis, material selection, machinability and automation.
• Ensure the efficient and timely transfer of proven technology concepts and knowledge from product development to advanced operations and global quality and manufacturing.

• Bachelors Degree in an Engineering discipline.
• 6+ years experience of leading product development projects and managing new product commercialisation in a high performance engineering industry (e.g. medical device, automotive, aerospace etc.). Experience in a regulated environment would also prove beneficial.
• Individual will be expected to help drive change through influence.
• Strong communication skills across a diverse audience and an ability to integrate well with AO, PD, Ops, Marketing, finance etc.
• Demonstrated use of best practice methodologies such as six sigma, SPC, capability analysis, R&R, DOE, DFM, GD&T
• Experience of statistical methods and design, product and process validations would prove beneficial.
• The individual should enjoy working in a dynamic and results motivated team environment.

• Develop and lead the implemented of Procurement & Sourcing Strategies, resulting in a strong supply base that continuously creates a sustainable competitive advantage.
• Develop Annual Sourcing Business Plans that will reflect year-over-year cost reductions, quality enhancements and overall continuous improvement.
• Provides strategic influence while building value-adding relationships with key suppliers and internal customer groups by applying advanced knowledge of purchasing principles, practices, tools and technology.
• Develop, implement and manage processes for supply-related problem resolution.
• Is instrumental in the development of all Commodity Strategies for the Galway site.
• Identifies and works closely with Vendor Engineering, Buyers, and Procurement Manager, Global Sourcing and individuals from other divisions/plants to identifying and executing Cost Reduction opportunities.
• Optimize the sourcing and procurement processes. They will benchmark best practices externally & internally and apply Lean concepts, supported by analytics, to design and implement optimally effective processes.
• Reviews, assesses and maintains a base line costing model for the key spend items in each commodity that is aligned with the strategic direction of the function or commodity and continually identifies and refreshes the model based on market dynamics.
• Supports the creation, approval, and implementation of new company-wide policies. Works with Management to implement trending, monitoring and enforcement mechanisms.
• Identifies, implements, and supports enabling technologies throughout the entire requisition to payment process
• Leads contract negotiations, contract management, and vendor management activities such as strategic reviews and site visits.
• Introduces new technology, new materials and/or new suppliers. Identifies “best in class” suppliers.
• Conduct Strategic Business Reviews with Key suppliers
• Evaluate in-sourcing / outsourcing opportunities.
• Optimize the number of suppliers on the AVL
• Identify opportunities to mitigate or reduce against risk in the supply chain

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• For those individuals that supervise others, the following statements are applicable:
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System

• Degree in Business or related discipline
• 10 years + experience in Purchasing/Procurement
• Good understanding of legal agreements
• Experience in Medical Device Industry is a distinct advantage

• Challenges will vary in scale from leadership of a cross functional team to deliver a specific result or to an individual leader of strategy or contract negotiations.
• Develop and ensure that sourcing strategies are fully implemented and executed.
• Manage products being transferred in and out of the various manufacturing sites.
• Proactively identify, report & manage constraints within the end-to-end Supply Chain which will impact on Customer Service levels.
• Generate and present daily / weekly / monthly reports and metrics as appropriate.
• Represent the “Voice of the Supplier” within the Organisation.
• Participate in NPI and product launches by partaking in meetings, offering          constructive advice and collaborating with the Operations, Marketing and Customer teams to ensure a successful product launch.
• Work on challenging assignments with clearly defined business objectives, solving problems and supporting the needs of Operations and other functions.
• Establish a competency around commodity pricing expertise, where relevant commodities pricing is tracked, monitored and understood allowing for forecasting intelligence/guidance to be provided and reflected in the annual standard cost setting
• Partner with our client’s Global Sourcing / Corporate to access the central repository of Best in Class suppliers as well as to leverage global business to access best pricing
• Working with other Commodity Managers in the Strategic Sourcing organization to identify major projects that need to be transferred to another supplier either for cost savings opportunity, rationalisation or for other business needs.
• Negotiating Long Term Agreements with prospective suppliers to achieve year over year cost savings and build alliances with strategic vendors and work with our clients Legal Counsel to streamline such agreements where necessary.

• 3rd level qualification in Business, Materials Management, Supply Chain Management/Logistics, IPICS or other equivalent is required.
• Proven track record with extensive experience in supply chain management
• Expertise in outsourced manufacturing and managing manufacturing and supplier agreements.
• Familiar with cGMP compliance requirements, best practices, purchasing controls in an FDA regulated medical device industry.
• Project Management experience and proven track record of successful leadership of high impact projects
• Ability to lead and support several concurrent projects and develop strong relationship within cross-functional teams.
• Experience in negotiations with suppliers and in commodity management capacity required.
• Strategic thinker: ability to see the big picture and translate this into operational objectives.
• Excellent communication skills, both written and verbal.
• Works with a sense of urgency and attention to detail at all times.
• The ability to work on your own or as part of a team.
• Demonstrates initiative and sponsors and implements change. Works cooperatively with others to produce innovative solutions.
• Solves problems by gathering data and using logic to arrive at decisions or solutions that achieve the desired outcome. Excellent data manipulation capability and analytical skills required.
• Flexible to work needs.
• Must be creative, able to multi-task and have a hands-on approach.
• Results, goals and measurement metrics oriented.
• Develops self and others, by building on strengths and addressing weaknesses. Seeks feedback and is receptive to new ideas and perspectives.
• Ability to influence others through presentation of facts, analysis and conclusions or solutions in a manner that demonstrates command of the content.
• Manage risk and uncertainty
• Ability to project manage, work under pressure and meet agreed and often tight deadlines.
• Excellent knowledge & computer skills in MS Excel, PowerPoint & Word.
• Ability to effectively prioritise workload and tasks to effectively meet established deadlines.
• Ability and willingness to travel.
• Have the highest levels of integrity in the successful completion of your work.

• Draw up study plans and implement studies in strict accordance with plan ensuring full GMP regulatory compliance.
• Liaise with the Quality Department for the generation of audit responses, facility replies, and deviation reports and for the compilation of study reports.
• Responsible for leading laboratory investigations.
• Responsible for reporting project progress information to Management.
• Provide technical training to scientific team as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Research and develop new methodologis to meet client requirements and/or company strategic objectives.
• Ensure all new methods are validated in accordance with ICH guidelines.
• Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
• Generate new and update current standard operating procedures.
• Generate risk assessments for various projects as required.

• M.Sc. or PhD in a relevant science discipline (e.g. Biomedical Science)
• A minimum of 2-3 years experience working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
• Experience in study design, assay development, ICH analytical validation and project management.
• Experience in Bioassays and model development.
• Experience in immunology, immunogenicity or other bioanalytical techniques.
• Ability to manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.

• Draw up study plans and implement studies in strict accordance with plan ensuring full GMP regulatory compliance.
• Liaise with the Quality Department for the generation of audit responses, facility replies, and deviation reports and for the compilation of study reports.
• Responsible for leading laboratory investigations.
• Responsible for reporting project progress information to Management.
• Provide technical training to scientific team as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Research and develop new methodologies to meet client requirements and/or company strategic objectives.
• Ensure all new methods are validated in accordance with ICH guidelines.
• Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
• Generate new and update current standard operating procedures.
• Generate risk assessments for various projects as required.

• M.Sc. or PhD in a relevant science discipline (e.g. Biomedical Science)
• A minimum of 2-3 years experience working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
• Experience in study design, assay development, ICH analytical validation and project management.
• Experience in Bioassays and model development.
• Experience in immunology, immunogenicity or other bioanalytical techniques.
• Ability to manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.

• Work with the Training team to strategically develop Operations Training and champion Training Essentials on site
• Coordinate, Manage & Measure the activities of allocated Operations Trainers.
• Provide Training, coaching & mentoring for Operations Trainers to empower a proactive team, encouraging continuous improvement & growth within the team.
• Carry out proactive training needs analysis & develop appropriate Training plans meeting Production Unit/business needs & Operational Training metrics.
• Demonstrate a primary commitment to patient safety and product quality.
• To ensure compliance with all areas of the Quality system and drive compliance to manpower Quality metrics.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements, and that they understand and comply with all other regulations governing their work.
• Facilitate the transfer of Product Builders to each Production Unit ensuring delivery in a timely manner to allow for training requirements ensuring minimum business impact.
• Work with Product Development on the introduction and training requirements for new products.
• Implement and operate in-house programs, practices, and procedures for training personnel.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Understands and proactively follows through on the Environmental Management Procedures that have been identified as relevant to position.
• When necessary provides on the job training, G.M.P training, I.S.O./EN training, safety training, First day and NEO programmes etc. as required
• May use and/or oversee contractors or vendors to develop and/or administer in-house training programs.
• Keep abreast of training and development research: learning theory, motivation theory, and new materials, methods, and techniques.
• Leads VIP projects to support and achieve a target of 8% COGS reduction year on year

• Bachelor’s degree or significant college course work, preferably in a communication, education or related field.
• Expertise in designing, developing, planning, implementing and assessing training.
• Demonstrated experience leading and coaching trainers.
• Demonstrated experience in delivering training to coaches and mentors.
• Expert knowledge of adult learning and training practices, especially in technical support contexts.
• Demonstrated experience in delivering training within a manufacturing environment, both within a classroom context, and on-the job learning.
• Demonstrated experience developing classroom activities and reviews, job aids, online tutorials and/or other training materials.
• Excellent communication skills for the purpose of knowledge transfer and skill development, including superior skill in explaining technical topics to novices and collaborating with subject matter experts and managers.
• Excellent coordination and organization skills.
• Ability to use multiple learning methods and link appropriate methods with subject matter.
• Excellent one-to-many and one-to-one communication skills in both classroom and tutorial settings.
• At least 5 year’s experience in a training role, covering both technical and soft skills training.

• Equipment Qualification and Process Validation
• Facility & Utility Validation
• Method Validation

• Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
• Participate on Divisional Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
• Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures.
• Represent validation at both internal and external audits.
• Ensure that QE?s and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
• Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
• Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
• Review/Approval of Validation/Qualification Documentation.
• Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
• Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met.
• Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures

• Bachelor?s Degree in Science /Engineering is required.
• Minimum of 2/3 years direct experience in a Validation Role in either Medical device or Pharmaceutical Industry.
• High level of PC skills required. The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
• Working Knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
• Excellent communication skills and attention to detail.
• Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs
• Have a good understanding of engineering and machine tool fundamentals.
• Lean Six Sigma training a distinct advantage.
• Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Must be willing to work as part of a multi-site team, be able to travel as part of the job.

• Demonstrates and promotes a commitment to improving patient safety, customer satisfaction and product quality.
• Coaches others in areas of expertise. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer and Design Assurance Technicians.
• Uses opportunities in project assignments to develop self & other team members.
• Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.
• Is an active member of the project team, partnering with other functions and leading execution on quality deliverables.
• Committed to the project’s success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
• Provide guidance in product development systems and design control requirements to project teams and sustaining engineering activities.
• Analyses, reduces and manages risks associated with the design, use and manufacture of the devices.
• Assures compliance by fulfilling regulatory requirements applicable to the medical device industry.
• Knowledge of regulatory requirements related to Product Development.
• Experienced in validation techniques, risk management, statistical techniques and compliance to regulatory requirements.
• Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
• Integration of Quality into all aspects of work by maintaining compliance to all quality requirements and driving continuous improvement practices.
• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
• Demonstrates project compliance to external regulations related to risk management, product development and design control during product certification, pre-market approval and quality system surveillance audits.
• Ensures project teams are aware of their commitment to patient safety, product quality, training requirements and they understand and comply with all other regulations governing their work.

• A graduate (HETAC 8) of Engineering, Sciences (or associated branch of learning) with a minimum of two years’ experience in a Medical Device or Pharmaceutical environment at Engineering level (product development or manufacturing).
• Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
• Identifies opportunities for improvements in product and process quality.
• A good communicator with the ability to influence other decision makers.
• Completes work assignments under limited supervision/guidance.
• Interfaces with other functions in a project team environment.

• Conduct validation activities in compliance with US and EU regulations, company procedures and EHS requirements.
• Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
• Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
• Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
• Execute qualification protocols as required.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• Prepare reports of executed protocols for review by QA.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions during qualification activities.
• Prioritise qualification activities in line with the project schedule.
• Co-ordinate qualification activities with engineering, construction and commissioning activities.
• Co-ordinate qualification activities with contractors and vendors as required.
• Co-ordinate qualification document review and approval.
• Attend identified training, required to fulfil the role of Validation Engineer.
• Assist in the development of training material for qualification activities.
• Participate in cross-functional teams as required.
• Domestic and international travel may be required.

• The successful candidate will have a degree qualification in science or engineering with at least 1-3 years experience in a manufacturing role.
• Knowledge and Interpretation of FDA/EMEA requirements applicable to the medical device is desirable but not essential.
• Good attention to detail.

• Effectively purchase raw materials, production supplies and capital equipment in accordance with the quality and financial systems.
• Work with the Manufacturing Managers to effectively plan materials to meet agreed production schedules.
• Work with the technical team to identify and deliver components on target to meet new product requirements.
• Develop a good business relationship with suppliers, establish their technical capability, understand their bottlenecks and work with them to source and identify new materials, manage potential stock-outs and material discontinuations.
• Monitor materials costs and ensure that suppliers maintain a competitive price range to enable our client to remain competitive in the market place.  Be proactive in sourcing materials as required with Quality, price and continuity of supply foremost in discussions with all Vendors.
• Monitor and rate supplier performance, provide feedback to the supply base on a regular basis in an effort to drive continuous improvement.
• Build a motivated, competent warehouse/purchasing team .
• Manage the receipt of raw materials and supplies in accordance with the quality system.
• Manage stock control and purchasing to ensure on time delivery, provide an excellent service level to our customers, while managing  inventory reduction in line with target inventory turns.
• Manage the movement of product to and from the contract sterilisers, schedule sterilisation in conjunction with the contractors, ensure accountability documentation is complete and that the integrity of sterile and non-sterile product is maintained.
• Manage shipment of finished product, samples and equipment through packing for safe transportation, organisation of appropriate cost-effective transportation and generation of documentation as per the quality system.
• Actively manage inventory to minimise inventory-carrying costs and ensure accuracy through cycle counting, effective location management and accurate record keeping in accordance with the quality system.
• Maintain warehouse areas to a high level of GMP, housekeeping and safety.
• Maintain open communication with other staff, customers, suppliers and hauliers.
• Manage waste material, recycling and environmental systems.

• The Materials Manager is responsible for the Buyer and the Warehouse Technician.
• In his/her absence the Operations Director will deputise.

• The Materials Manager should have a primary degree in engineering or business or be certified in APICS OR IIPMM.
• S/he should have a minimum of 5 years materials experience including at least 1 year in a medical device/pharmaceutical and/or diagnostics manufacturing environment.
• Must have a good working knowledge of the medical device industry and of  the required quality systems.
• Strong negotiating, communication and influencing skills.
• Ability to effectively manage a wide range of diverse activities simultaneously.
• Self starter with good organisational, motivational and inter-personal skills.
• Practical levelheaded individual who is prepared to actively lead and  manage a team.
• Strong management and leadership skills.

• Support and administer designated Applications.
• Implement, test and prepare documentation for Applications.
• Provide backup to the other IT Specialists and IT System Analysts in supporting Applications.
• Adopt root cause analysis in all aspects of problem determination, decision-making to help prevent re-occurrence.
• Liaise with vendors to support the Applications.  Monitor and evaluate any contractors or external support services and report service or potential service issues.
• Manage end user calls through recording, analysis, escalation & close out within the SLA and in accordance with best practices.
• Provide regular status reports on calls and projects being worked on to the Associate Director or Technical Services Manager.
• Work as part of the IT Projects team to ensure the IT implementations and projects are in line with IT and Site requirements.
• Develop and maintain procedures relating to system support responsibilities in SOPs/Work Instructions.
• Adhere and improve SOPs and any policies i.e. Computer System Validation; ITMS Policies and GAMP.
• Ensure that the application listing data for designated Applications (GXP and non-GXP) is maintained and developed.

• Either of the following Certificate/Diploma Chemistry and Computing; BS/BA Computer Science; Information Systems or equivalent work experience.
• Strong Application knowledge, excellent problem solving skills.
• Excellent oral and written communication skills.
• Familiarity with windows operating systems.
• Familiarity with Oracle and SQL databases.
• Ability to interact readily with personnel across different departments.
• Proven track record in your current role is essential.
• Expertise in Document Management Systems, SharePoint 2010, Microsoft SSIS and Microsoft BI
• Responds positively to changing circumstances and priorities.
• Proven track record in your current role is essential.

• Operations lead for New Product Introduction programs, with specific focus on Project Planning, Product Quality, Cost minimisation, Capacity Analysis, DFM (Design for manufacture), Manufacturing Process introduction & associated Validation.
• Provides strong, capable leadership to the Project Team(s) encompassing of key professionals from Quality, Sterilisation, Production, Manufacturing Engineering, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Equipment Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams & operational deliverables.
• Collaborates closely with the Process Development Department & Value Stream to ensure that all new products and processes are introduced into production compliantly, on time, within budget and are operationally successful. Ensure no adverse impact on Quality, Service or Cost. Drive activities to mitigate adverse effects on process capacity & yield.
• Develops, communicates, tracks and executes detailed project plans. Reports accurate and timely project metrics/status to stakeholders as required
• Liaises with Quality & Regulatory Affairs to ensure all Quality System and appropriate regulations are met.
• Determines capacity requirements and implements solutions in support of Design & Process Validation builds and product launch activities.
• Drives implementation of Lean throughout the project phases through to launch.
• Develop quotes and costing information, driving standard cost to less than existing predicate platforms. Drive capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
• Liaises with Logistics in driving shipping & sterilisation activities.
• Identifies and escalates unresolved obstacles to the success of the project. Leads resolution of problems that impede project progress.

• Bachelor Degree in Engineering or Science discipline or equivalent required
• Minimum of 5 years project management experience in a regulated industry essential. Has demonstrated  ability to successfully plan, prioritise, multitask and organise multi-disciplinary team(s) to successfully achieve large project deliverables
• Has applied knowledge of FDA & International medical device regulations
• Ability to lead, motivate and influence a cross-functional that does not report directly to this position
• Strong communication and interpersonal skills
• Excellent analytical and problem solving skills
• Experience in process validation preferred

• To produce standard operating procedures (SOP) and component history records (CHR) used in the production of the Company’s products.
• To research, design, build, evaluate, install, operate, and maintain all of the following; Tools, fixtures, Jigs, production aids, production processes and other systems (made or bought), which are required to make the Company’s products.
• To resolve problems encountered production processes.
• To provide solutions for the development of customer’s products, i.e. design for manufacture, selection of materials, and resolution of processing problems or providing alternatives to customer designs.
• To develop programs for PLC controlled equipment, including, but not limited to, Laser cutting/marking/welding, Electro Discharge Machining, Electro Chemical Machining and other bespoke processes.
• To continuously improve the manufacturing processes in the Company using Lean/GROWTTH principles.
• To know basic electrical principles

• To prepare and complete IQ(s), OQ(s) and PQ(s) as required.
• To resolve, (with the rest of the Team), yield issues, determining root causes, implementing corrective actions and preventative actions.
• To conduct feasibility studies, ensuring that the correct processes are chosen for the products that the Company produces.
• To drive the OEE system ensuring the best use of Company assets.
• To ensure that all safety procedures, maintenance/service schedules and supplier agreements are strictly adhered to.

• To plan, lead and control projects along customer and Company time-lines.
• Develop and maintain relationships and lines of communication with colleagues and peers in the Medical Device Industry.
• Keep your skills current and be conversant with the latest developments in technologies and materials which are relevant to the Company’s business.
• Engage constructively with other functions within the Company to drive continuous improvement.
• To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
• To meet and/or exceed the Milestones and Goals agreed with the Company.

• A very practical, constructive and proven approach to problem solving.
• Mechanical and/or Manufacturing Engineering qualification.
• Trained Toolmaker or Mechanical Fitter an advantage.
• Previous experience in NPI.
• Excellent analytical skills.
• Understanding of ergonomics and its application in a production environment.
• Experience in Lean Manufacturing/Six Sigma an advantage
• Excellent communication skills.
• Must be competent and capable of leading a team.

• Ensure a safe working environment at all times (safety clothes etc.
• Troubleshoot and resolve issues on a daily basis
• Provide maintenance schedule data to Planning/Recruitment.
• Follow production plan in SAP
• Retain spare parts inventory as appropriate.
• On a daily basis report to the Assembly Manager
• Record production information in SPIN and OEE as appropriate.
• Participate in Improvement teams
• Responsible for the working condition of the Assembly Machines
• Drive the forklift.
• Maintenance of machines (as allocated to each individual) in line with the maintenance schedule.
• Calibration of machines.
• Ensure calibration pumps maintained. Resolve any issues flagged by operators to ensure that conform product is produced.
• Define specific assembly operating practices as required.
• Coordinate with Order Planning a suitable time slot at predefined intervals to carry out Preventative Maintenance (PM) on their machine.
• In conjunction with the Maintenance Manager ensure that the preventative maintenance and breakdown history including usage of spare parts is properly logged.
• Ensure that machine datum points are defined and clearly marked during the PM. Ensure that datum points are defined and recorded in the machine manual.
• In event that machine datum points have to be moved after fixing, reasons for moving must be reported to Maintenance Manager.
• Manages in conjunction with the Maintenance Manager the level of spare parts and reorder them as required.
• Follow up with other Technical personnel whom may have carried out repairs to machine, must ensure that any follow up actions required for their respective machines are completed.
• Communicate to all Assembly staff regarding maintenance or changes or breakdowns etc. regarding the machine.
• Carry out not essential modifications to machine.
• Become the resident expert in operation of the process and machine. Ensuing that all relevant drawings and machine information is readily available.
• Monitor overall machine performance such as machine down time and scrap generation with the view to developing an action plan to improve
• Carry out deep cleaning of the machine, i.e. take covers off the machine and clean out components and product from inside and under machine.
• Update the machines production status board with production, OEE, Scrap and Scrap cost figures.
• Maintenance of machines (as allocated to each individual) in line with the maintenance schedule.

• Be the Subject Matter Expert with regard to Acceptable Quality Standards for products and processes.
• Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Represent QA as the first point of contact for daily line support issues.
• Troubleshoot product and process related issues and identifies root cause.
• Complete investigation and analysis of customer complaints.
• Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these.
• Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
• MRB: Provide disposition for any non-conforming product and identify appropriate corrective action with other support team members.
• Perform internal quality audits.
• Trending and analysis of key Quality metrics.

• Minimum of 2 years’ experience in a QA role.
• Minimum qualification: NCEA diploma in related discipline.
• Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
• Good knowledge of statistics would also be an advantage.
• Experience/training in problem solving methodology.

• Manufacturing Management:
• Logistics
• Product release

• Establishing and re-establishing manufacturing as the business model evolves
• Ability to negotiate terms with manufacturers and suppliers
• Can work around a product roll-out plan
• Understanding cash flow
• Business model analysis
• Deep understanding for Quality Control

• Establishing a location for assembly and packaging
• Ability to find low-cost assembly solutions
• Knowledge of Design-for-Manufacture
• Capability to work with product designers and tool makers
• Someone who will protect our client’s brand integrity at all times
• Deeply understands Brand Value

• Ensuring supply meets demand
• Being available and responsive 24/7/365
• Sales forecasting
• An understanding for the trade-off between quality and production
• Good with numbers.

• Higher level degree
• 5+ years industrial experience
• Understanding of quality and validation processes for immunoassays and electronics

• Manage the Customer Operations team to achieve its goals and objectives.
• Manage communications/relations with Customers that are supplied products from the Ireland Campus and conduct Customer satisfaction monitoring.
• Manage activities with 3PL (IEC).
• Manage departmental budget to ensure the delivery of financial results.
• Manage, lead and participate in specific projects as required
•  Responsible for the Customer Visit program & Sales Training Programs.
• Responsible for creating a positive team environment and recruitment, engagement, coaching and development of Customer Operations team.
• Responsible for building great relationships with both internal and external customers. Ensuring we maintain strong and binding relations with core Customer Base by delivering Best-in-Class order fulfillment processes and Relationship Management.
• Liaise with Business Unit Leaders and Supply Chain to ensure excellent service level delivery to the Global Distribution Network.
• Introduce continuous performance improvements to enable outstanding service to the Global Distribution network.
• Ensure the implementation, enforcement and compliance with all the company’s regulatory requirements including Quality, Environmental and Health & Safety.
• All other duties as assigned.

• Degree level qualification in Business, Marketing, Supply Chain or related area is required.
• Previous people management experience essential.
• 3+ years experience with Customer Services and Logistics management in a manufacturing environment essential.
• Experience with integrated information systems in a manufacturing/distribution environment necessary.
• Experience required in a team based environment with emphasis on accountability for service levels, inventory management, standard cost and expense control and quality/GMP compliance
• Proven Leadership ability.
• Excellent presentation and communication skills.
• High level of PC skills

• Provides HR guidance/support to customer teams and leaders in talent acquisition and management, employee engagement and development, change management and process improvement processes
• Partners with leaders to build high team engagement and implement excellent communication and people management practices
• Coaches and partners with leaders on issues affecting engagement, performance, development and organization effectiveness, helping to determine root cause analysis and recommends appropriate solutions.
• Is a subject matter expert (SME) regarding best practice HR processes and has an up to date understanding of employee legislation and implications in practice
• Is an employee advocate that builds trust and credibility with employees and leaders.
• Voices the employee perspective is an objective, fair and balanced manner and is a key influencer in decision making situations.
• Conduct and manage investigation of complaints and concerns in a thorough, fair, objective manner; assess the severity, involve appropriate individuals and facilitate appropriate action based on policy and practice
• Project managed process improvements initiatives and company events/activities
• Partners with HR Centers of Excellence to address and satisfy customer requirements and applies knowledge of key business drivers in making decisions
• Presents, trains and/or facilitates employee and leader development programs. Supports communication on and utilization of performance management tools & processes and compensation & rewards programs.
• All other duties as assigned

• Degree in Human Resource Management or equivalent is necessary. Masters Qualification in a HR related discipline is an advantage.
• Minimum of 3 years previous experience is a HR related role is requiredA sound understanding of contemporary human resources trends and the ability to benchmark/network.
• Customer service skills. Is very helpful, approachable, accessible and seeks to proactively meet customer’s needs.
• Excellent Communication and Influencing skills. Can effectively listen and is articulate verbally and in writing.
• Excellent influencing talent
• Facilitation, mediation and negotiation skills
• Integrity, honesty, confidentiality and builds trust with other
• Self-assurance and confidence
• Ability to learn, grow and drive own professional development.
• Analytical and an effective decision maker
• Team-player and flexible
• Able to plan/organize workload and can multitask
• Microsoft Office Computer skills

• Oversee the development of operational standards to be used in the plants for capacity evaluations, budget planning and as a basis for operational productivity and performance measures.
• Establish robust standard times and output targets based on a stable demand model across all business units.
• Create a process that systematically maintains the accuracy of the standards on file.
• Assist in the development of a plant capacity planning model (equipment and people).
• Drive program to develop and implement standard operation sheets across Manufacturing Operations.
• Develop and implement a Kaizen program to drive focussed improvement in selected areas
• Support any activity that proposes changes to the workplace layout to ensure compatibility with lean principles.
• Share in the creation and delivery of a standard approach for the training of operators and support staff in lean manufacturing principles and practices.

• Bachelors of Science degree in Industrial Engineering
• Demonstrates an innate talent for problem solving.
• Strong working knowledge of the principals of Lean
  Manufacturing.
• Requires 5+ years experience in Lean Manufacturing/Kaizen
  implementation.
• Requires strong communication skills, both written and
  verbal, and be able to work in a team environment.
• Understanding of lean principles and the ability to
  facilitate groups towards the implementation of lean in their
  production areas.
• Have a competent working knowledge of Microsoft Office
  applications.
• Ability to work independently and handle multiple priorities

• Value Stream (Production Unit) Support
• Leadership of value stream quarterly forecasting process for scrap, labour, overhead and inventory
• Key role in the annual budgeting/planning cycle process, targeting annual standard improvement rates and setting annual standards
• Member of value stream business projects and support to value stream management
• Finance rep to value stream key decision
• Financial Reporting
• Ownership of cost centre spend analysis, reporting and control for value stream and other key cost centres
• Ownership of selected KPIs for the site
• Project Work
• SAP/MES (factory floor system change) team member

• Educational Requirements: CIMA/ACCA/ACA qualified
• 7-10 years experience with 3 years at a senior level in a multinational manufacturing company
• Exceptional analytical skills
• Demonstrated Project Management
• Strong interpersonal skills & personal drive
• Advanced Systems Skills (SAP experience highly desirable)
• Advanced Excel Skills
• Enthusiasm and willingness to be successful in a demanding environment
• Previous People Management (1 / 2 direct reports) advantageous

• Organisation and co-ordination of a production team to manufacture quality product on schedule and in a safe and efficient manner in compliance with GMP
• Initiate and drive production and quality improvement projects in line with the Company requirements
• Drive elimination of waste projects with an emphasis on yield improvement
• Collaborate with interdepartmental colleagues on lean manufacturing projects to improve productivity, efficiency and quality standards
• Responsible for the planning and scheduling of multiple products in accordance with customer lead times
• Demonstrate strong problem solving abilities
• Management of production resources ie people, equipment, time, etc
• Communicate with other teams on production related issues
• Maintain positive employee relations
• Completion of timely performance reviews and appraisals
• Recruitment of production employees in conjunction with HR
• Implement company policies in conjunction with HR
• Formulate and implement training plans to meet compliance, versatility and development needs
• Maintain a very high standard of housekeeping and GMP compliance
• Develop a strong team culture through communications and team leadership
• Perform operations in accordance with established safe working procedures, regulations, standards and general safety rules, ensuring that attention is given to special hazards associated with the particular area of work
• Provide information on environmental, health and safety issues to all team members
• Report and document all incidents / accidents which may occur during the course of work and carry out and assist in al investigations and follow-up.

• 3 years’ experience as a production supervisor or similar role
• Demonstrated organisational and planning abilities
• Experience of Quality Systems, Lean Manufacturing or six sigma an advantage
• Strong leadership, inter-personal and team skills
• Excellent communication skills
• Technical aptitude
• Ability to work on own initiative
• A relevant qualification is desirable (manufacturing management / or production / engineering related discipline)
• Medical device background a distinct advantage.

• Month end close for cost accounting related functions
• Developing and maintaining the standard cost system for current and new products
• Updating and develop the current SAP system for cost accounting information
• Managing all costing - fixed, variable and production
• Monitoring and Investigating of labour, material, and overhead absorption variances
• Understanding impact of currency and freight on price variances
• Ensuring cost of goods sold are updated correctly on a monthly basis, all variances particularly price variances are correctly accounted for
• Advise management on costs effects and pricing on special orders
• Product costing and ensuring stock is correctly recorded and valued
• Stock control and preparation of reconciliations of stock
• Ensuring appropriate physical verification of stock
• Assisting with financials surrounding annual business plan, budget
• To assist in preparing the supporting documentation and information requests needed by external auditors.
• Any additional duties that maybe assigned from time to time

• Ensuring all key controls over labour, materials and stock are implemented and adhered to Identify any general control weaknesses, recommending relevant improvements

• Assisting in board pack material and presenting on costing trends
• Reporting on variances analysis
• Analyse data & report findings to the Financial Controller so as to highlight business issues & recommend actions as necessary.
• Provision of accurate monthly and ad hoc reporting to management when required for review and decision making purposes
• Support Production and Lean Manager in the collation, analysis and preparation of manufacturing/costing reports
• Leading operation meetings re variance reporting

• As a finance team member, working with Production and Lean Manager to maximise usage of the system for effective running of the business
• Support Evaluating cost reduction initiatives
• Process improvement and systems upgrade involvement
• Responsibility for ensuring regular analysis of operational figures and determining areas for efficiency and cost saving to drive improvements
• Support processes for improvement on reduction of stock losses

• Candidate must be a Partially Qualified/Qualified CIMA accountant
• Four years + experience in a similar cost accountant role in a manufacturing organisation
• Experience with SAP /ERP systems
• Excellent written, oral, interpersonal and communication skills
• Highly proficient in Microsoft Office, in particular Excel
• Excellent attention to detail
• Adaptable, mature attitude
• Ability to work within team environment
• Ability to work on own initiative

• Assign work schedules to production operators and technicians.
• Monitor work schedules and ensure personnel are utilized efficiently.
• Work with Director, CPG Manufacturing on issues and corrective action
• Train operators and technicians on Unicom Engineering Policies and manufacturing procedures.
• Perform test and troubleshooting functions; train others, as required.
• Lift servers in and out of testing racks consistently.
• Meet with production manager and sales department on daily basis to review and prioritize ship schedules and manage line accordingly.
• Maintain a clean and well organized work environment.
• Reviews time cards, time off requests, performance reviews and other supervisory duties.
• Learns about Company’s business as appropriate.
• All other duties as requested by supervisor or department head.

• Excellent leadership abilities.
• Requires in depth knowledge about the companies products and services.
• Good understanding of PC hardware and software
• Diploma/Degree in Business Studies or Electronic Engineering.
• 3-5 years of relevant experience.

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives.
• Ensure compliance for both yourself and team to mandatory training requirements.
• Supervising and exercising functional control of the laboratory such that a compliant, cost effective and efficient service is provided.
• Maintaining adequate instrumentation and lab facilities.
• Maintaining safety awareness in the laboratory.
• Training and development of laboratory staff.
• Overseeing the analysis of finished product, in-process, R&D, validation samples and Stability Samples.
• Supervision of method validation and analytical technical transfers from donor sites.
• Final review and approval of laboratory results, protocols, reports SOP’s etc.
• Provide technical guidance/ trouble shooting in the event of equipment failure, deviations or out of specification results.
• Selection and recruitment of analytical staff in conjunction with human resources.
• Conduct performance reviews of direct report.
• Represent the laboratory on cross functional project teams as required.
• Attend and represent the Analytical Laboratory at various meetings as required and communicate the required information as required.
• Liaise with various operational departments to ensure that the laboratory meets and exceeds the plants requirements.
• Drive continuous improvement within the laboratory in terms of Quality, Compliance and Efficiency using tools such as LEAN and Six Sigma.

• A post graduate qualification in Analytical Chemistry or related discipline would be a distinct advantage. A Hetac Level 8 qualification is a minimum requirement.
• Knowledge of all current cGMP requirements is essential.
• Thorough knowledge of HPLC (Waters Systems and Millennium software), GC, GC/MS UV, FTIR, N- IR required.
• Excellent interpersonal and communication skills with good leadership abilities.
• Proven people management skills.
• Experience working in an FDA environment is essential

• Working with the Sales team, deliver effective and efficient execution of the trials schedule based on sales/company objectives and orders received which effectively achieves output targets, delivery dates and key performance metrics.
• Ensure that new products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
• Maintain effective communication with the production manager in order to schedule required equipment, resources & ensure the successful transfer of new products into production.
• Support and provide technical input on all new products, customer queries and customer trials to meet key performance metrics, through direct communication with the customer or sales team member as defined by the Sales director.
• Project manages and leads cross functional teams with responsibility for the introduction and validation of new equipment /technology in the extrusion area.
• Project manages and leads cross functional teams with responsibility for the introduction and validation of new processes for strategic customers in the extrusion area.
• Attain technical expertise in extrusion technologies and materials and communicate and train extrusion personnel in the knowledge. Understand current processes taking a hands-on approach to understanding how these can be applied to new opportunities
• Support the Extrusion and Quality Manager on resolution of technical and quality issues. Champion structured approach to problem solving within the organisation using lean tools and 6 sigma principals.
• Support the extrusion manager/project leader on new technology/ tooling/ materials required to meet production and sales objectives.
• Maintain work areas, equipment and supplies in a manner which conforms to the requirements of the our clients quality system, particularly housekeeping, GMP and safety.
• Ensure all aspects of work order packages are completed in a timely and accurate manner as specified in the quality system to meet shipment dates.

• The new products engineer will have a primary degree or equivalent in Polymer, manufacturing or mechanical engineering.
• Medical device or manufacturing experience is essential.
• Hands on experience in extrusion and plastics material knowledge are essential.
• Must have a good working knowledge of production/R&D and quality system requirements in the health care industry.
• S/he needs strong communication and influencing skills.
• Have the ability to effectively manage a simultaneous range of diverse activities.
• Be a self-starter with good motivational and inter-personal skills.
• A Practical level-headed individual with strong technical ability.
• Have an ability to work hands-on engaging with cross-functional groups, equipment and materials vendor to resolve technical issues.
• A structured approach to problem solving based on the utilisation of data.

• Development and implementation of Strategic Sourcing strategies for our client that are aligned with corporate / divisional requirements
• Partnering with the all stakeholders to review spend analysis and identify opportunities for tenders, to lead to cost savings and increased contract coverage and
• On-going monitoring of  performance metrics and trouble shooting as required
• Defining policies & procedures and controls within sub processes as requested
• Coordinating and partnering with suppliers and internal customers to deliver best practice operations and communications
• Determining sources of supply for non-inventory purchases, ensuring that these suppliers are approved in an efficient and effective manner
• Strategy execution for key commodities on a global basis, when required, and development and optimisation of the supply base.
• Working with peer in the Divisional supply chain organization to identify major projects that need to be moved to another supplier either for cost savings opportunity or for other business needs.
• Negotiating Long Term Agreements with prospective suppliers to achieve year over year cost savings and build strong relationships with strategic vendors.
• Supporting all New Product Introductions to ensure that all quality, delivery, and pricing objectives are being met, utilising leverage within our existing supply base where possible
• Foster communication and teamwork within and across organizational boundaries
• Lead periodic supplier site visits to maintain business understanding and monitor changes
• Responsible for Leading and Coordinating periodic business reviews with cross-functional representation.

• Business Degree or relevant 3rd level business qualification or Attained a third level qualification in a business or technical field
• A purchasing qualification, such as the IIPMM certificate or diploma, an advantage
• Minimum of 5 years relevant experience in Strategic Procurement (experience in medical device an advantage)
• Demonstrated ability to lead, develop, motivate and influence others in a  dynamic high pressure environment.
• Experience in negotiations with suppliers and in commodity management capacity required and contract knowledge
• Specific experience in the areas of quality, supplier development, procurement, materials management, and planning
• Project Management experience and proven track record of successful leadership of high impact projects.
• Excellent verbal and written skills, ability to effectively present projects, status, etc.
• Strong computer skills including Advanced Excel, PowerPoint, and Project
• Must be willing to work in a results based, fast-paced environment, with minimal supervision.
• High aptitude for understanding systems, gathering data and performing research.
• Medical device and/or regulated industry experience preferred.

• As part of the New Product Development team provide input to design tangibles and risk analysis during new product development and release.
• Prepares, reviews, analyzes and files appropriate regulatory documentation (e.g. 510ks, FDA registration and listings, regulatory assessments, product technical files to comply with European Medical Device Directive).
• Liaise with the US Regulatory personnel, manage product regulatory registration activities for all new and transferred products per project timelines.
• Assess proposed changes for regulatory implications and implementation of identified actions to maintain product registrations in impacted countries.
• Provide technical data to all locations in support of country specific product registrations and regulatory requirements.
• Co-ordinate CE Marking activities with US Regulatory personnel, including new submissions and file modifications as required.
• Investigate complaints for medical reporting and filing to the appropriate authorities if required.
• Reviews labelling and literature for regulatory concerns.
• Liaise with Notified Body and Irish Medicines Board as Competent Authority in all technical matters relating to product approvals, changes and issues.
• Represent our client with various regulatory bodies, such as Irish Medicines Board and Irish Medical Devices Association.
• Ensure compliance locally with current regulatory requirements as per our client’s Divisional and Corporate Recall and Regulatory procedures.
• Provide support to day to day product hold and recall related activities and procedures.
• Co-ordinate preparation, take participation in and complete follow up for regulatory/recall related activities and procedures for internal, Corporate and third party external regulatory compliance audits.
• Prepare quality reviews and trending activities.
• Lead & Participate in cross-plant and divisional project teams in areas of compliance and quality systems improvement.

• A Degree/Diploma in Quality Management or equivalent discipline is required.
• A minimum of 2 years experience in a Quality Assurance compliance position is required; exposure to Regulatory Agencies such as the FDA and/or Notified Bodies is desired.
• Excellent communication, organisation and time management skills with the ability to manage several priorities at once will be required as will a high level of flexibility with a high level of commitment to success.
• Strong project management capabilities.
• High level of PC skills required.

• Developing processes, systems and tools that will be used for determining manufacturing costs for current and new products.
• Develop and implement policies for non-recurring project costs (eg Validations)
• Evaluating relative positioning of existing and new products to ensure that prices are consistent with relative volumes, complexity, strategic customer importance and customer value proposition.
• Liaise with finance to ensure appropriate data is available for input to costing decisions
• Provide cost and price analysis to support management decisions to optimise revenue and margin maximisation

1. Development of systems, structures and tools to accurately generate costs and pricing for the Galway site products
2. Roll out to all sites (MN, CA & SG)
3. Develop the costing / pricing function as a key input to strategic decision making across the organisation

• Establish and document costing methodologies & processes
• Develop templates for use in quotes and proposals.
• Understand the Request for Proposal (RFP) to develop competitive costing strategies.
• Develop and produce compliant costing/pricing, including cost models and templates, formats and rationale in accordance with company policies
• Keep informed of changes in pertinent company strategies, and update costing policies and procedures as applicable.
• Develop competitive costing/pricing strategies that are defendable
• Establishing processes and framework for Financial components of project submissions
• Understanding customer value proposition in order to maximise margin opportunity
• Conducting market analysis to support pricing decisions
• Developing costing strategy to correct any misalignment of current prices
• Provide costing and pricing direction for contract negotiation and renewal process

• Minimum five years experience creating and analyzing financial data in a medical device environment
• Well-developed financial modelling, analytical and problem solving skills.
• Ability to review and compare data to identify inconsistencies and determine priorities.
• Good knowledge of manufacturing processes and drivers for cost within the manufacturing operation
• Experience using enterprise-wide information systems (Oracle) preferred
• Customer interfacing experience; supporting cost data used in bid packages
• Strong teamwork and presentation skills to all levels of the organization.
• Strong analytical skills with excellent attention to detail

• Engineering Qualification in Design, Polymer, Medical, Mechanical, Biomedical or equivalent.
• Minimum 5 years experience in Catheter and Medical Device design and extensive knowledge on the use and requirements for Catheter design. Comprehensive knowledge of resins, materials, packaging and other components required for Catheter and Medical Device Design.
• Comprehensive knowledge of the manufacturing processes used for manufacturing catheters used within the Neurovascular  together with stent delivery systems for the Cardiovascular and Peripheral vascular areas, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.
• Solid modelling and CAD skills
• ISO and FDA standards for Catheter and Medical Device Design
• ISO and FDA standards for Design control including Design Inputs, Outputs, Design Verification
• Organisation of Clinical Trials etc.
• Knowledge of Sterilisation methods and associated material selection criteria.
• Rapid Prototyping Techniques.
• Process Product validation requirements.

• Designing innovative catheters and Medical Devices to meet and exceed the requirements of our Customers. Selection and design of materials, components, tubing and packaging.
• Working with the New Product Introduction teams to ensure Product Designs include DFM (Design for Manufacture) and can be manufactured at competitive costs.
• Working with the Business Acquisition teams to design products to meet or exceed the scope of Customer requirements.
• Compliance with the requirements of FDA and ISO standards for Catheters and Medical Devices
• Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design History Files in accordance with our clients procedures and Regulatory Standards.
• Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc. by providing technical support, as required.
• Meeting the agreed timelines on Designs and other associated outputs.
• Organising the manufacture of prototypes, as required.
• Leading or participating in design tasks such as clinical trials, functional studies, testing including biocompatibility, aging, design verification, etc.
• Completing other tasks as assigned.

• Develop a Project Portfolio roadmap to support our client’s Global Plan strategy.
• Lead a team of Project leaders.
• Work with stakeholders to identify the most compliant cost effective method of project implementation to deliver the strategy.
• Ensure a consistent methodology is adopted in delivering the program of projects.
• Identify long- term resource gaps in delivering the program.
• Develop integrated working and review processes with senior IT stakeholders.
• Liaise with Finance on budget reconciliation, CAR preparation and approval process with GPB ( Global Process Board ).
• Consistently support the PMO (Project Management office) to continuously raise the standard of project leadership and upgrade methodologies.

• Bachelors degree or equivalent
• 10+ years of relevant experience.
• Supply chain experience in medical device or pharmaceutical industry (desirable).
• Working knowledge of financial processes
• Experienced ERP / Planning Systems User
• Persuading, influencing and managing others
• Strong organization skills and an aptitude for planning.
• Can drive continuous process improvements.
• Accuracy with attention to detail
• Ability to translate complex situations into simple working solutions
• Proactive approach
• Proficient user of MS Office, Excel, Word, Powerpoint
• Able to work with no supervision
• People leadership with an aptitude for coaching and developing leaders
• Able to set and manage capital / OPEX budgets

• Regional S&OP integration
• Roll-out standard S&OP processes & templates to ASPAC, US, EMEA, LA, Canada & Japan
• Develop regional S&OP programs to deliver significant long-term improvement in KPI’s
• Integrate regional S&OP processes into the Global S&OP process for our client.
• Liaise with the MD&D S&OP Council to ensure regional alignment across all MD&D franchises
• Responsible for influencing large-scale regional teams who are responsible for collecting, analyzing, consolidating, and reporting Supply Chain data, aiming to;
• Improve LIFR
• Optimize Inventory Levels
• Deliver Cost Improvements
• Review and develop long term regional strategies to deliver improvements in Performance Metrics, providing appropriate resource prioritization and negotiation of non-Planning / Supply Chain resources
• Interface between and escalation point for GMB level commercial, finance and supply chain partners – supporting Monthly, Quarterly and Annual reporting & business analysis
• Responsible for identifying regional leaders and teams to improve supply chain effectiveness and performance, primarily through excellent technical ability, coaching and leadership
• Provide clear leadership for regional  S&OP teams
• Managing S&OP Coordinator who is responsible for BO, Supply and Exec review meetings.
• Continuing to develop a forward looking S&OP process by changing the mindset amongst all SC functions to focus on the future state
• Lead our clients Regional S&OP Processes
• Integrate Regional S&OP processes into the Global S&OP process
• Develop an Instrument Joints S&OP process to address the current dysfunctional process and improve the current service levels by increased focus on instruments
• Overall ownership of the Instrument SC from end to end with clear accountability and responsibility for each step in the process
• Developing a forward looking S&OP process for instruments by aligning all functions with the SC
• Working with regional teams to stream line instrument investment depending on the processes within each region
• Acting as a key member of the Instrument Improvement initiative team
• Bringing instruments into the global S&OP process to ensure full alignment and increased focus on improved service

• Bachelors degree or equivalent
• Green Belt certification
• Black Belt six-sigma certification (Desirable)
• APICS Certification
• 8+ years of relevant experience.
• Supply chain experience in medical device or pharmaceutical industry.
• Working knowledge of financial processes
• Experienced ERP / Planning Systems User
• Persuading, influencing and managing others
• Strong organization skills and an aptitude for planning.
• Can drive continuous process improvements.
• Accuracy with attention to detail
• Ability to translate complex situations into simple working solutions
• Proactive approach
• Proficient user of MS Office, Excel, Word, Powerpoint
• Able to work with no supervision
• People leadership with an aptitude for coaching and developing leaders
• Able to set and manage capital / OPEX budgets

• Have demonstrated experience and implementation of using lean manufacturing, six sigma, or similar analysis tools.
• Proven track record of implementing projects.
• Use of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Excellent interpersonal and communication skills.

• Degree qualified in a relevant engineering or science discipline.
• Five years’ experience in a regulated environment.
• Experience in manufacturing, mechanical, electronic, production etc.
• Proven experience of implementing six sigma and/or lean continuous improvement projects.
• Medical device experience and advantage but not essential.

• Working as part of a team responsible for Regulatory Activities and issues occurring at the company.
• This includes reviewing of Technical Files and providing information to US International Regulatory Affairs groups for other submission activities as well as regulatory issues relating to labelling, releases and change requests.
• Assist in preparation of Design Dossiers/Technical Files for the products, in conjunction with divisional personnel and QA personnel.
• Review and approve documentation related to product release through the CR process
• Provide input, review and approve facility regulatory activities such as labelling.
• Provide Emerging Markets submissions information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for all the company’s products.
• Provide updates on regulatory requirement changes, either on individual product specification or quality systems.   Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

• Bachelor’s Degree in Engineering, Science or Quality Assurance.
• A minimum of 3 years’ experience in a Health Care environment.
• Experience of CAPA’s and internal audits is desirable.
• Excellent communications skills.
• Strong team member with the ability to identify and drive quality improvements.
• Experience in FDA regulations, ISO 13485 and the Medical Device Directive are desirable.
• Good administrative/organizational skills.
• Excellent attention to detail is required.

• Responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
• Provide independent regulatory leadership and guidance to business partners for regulatory notifications arising from process changes in operations.
• Main point of contact for regulatory activities associated with product transfers to and from manufacturing site.
• Prepare and submit 510(k) s, PMA Supplements, Design Dossiers and Change Notifications related to Cork manufacturing process changes.
• Interface with regulatory agencies.
• Review proposed changes and evaluate regulatory impact in US and EU markets.
• Develop departmental systems and best practices, including incorporating new requirements.
• Provide Regulatory Affairs support for internal and external audits and inspections.
• Plan schedules for regulatory deliverables for projects and monitors progress through completion.
• Working with international and US regulatory groups to develop knowledge of regulatory requirements for process change notification (including Class 111's) to a recognised expert level.
• Participant at IMDA industry association working groups as appropriate. Main point of contact for the facility for IMB.
• Continuous Improvement Focus.

• Degree level qualification (Science- biological sciences, bioengineering, engineering, medical/health field, or other technical field).
• 5.-7 years of experience in Regulatory Affairs, Clinical Affairs or Quality within a medical device, pharmaceutical, or similar regulated industry.
• Previous experience with change control for US and EU Class III medical devices.
• High Attention to Detail Pro-active approach to work.
• High Standards Flexible.
• Excellent Communication Skills Comfortable with reading and analysing technical (Written & Oral) documents.
• Team Player.
• Computer Literate.
• Demonstrated Project Leadership.
• Work Independently.

• Designing of formulations and potentially novel drug delivery systems, as required, for our client’s proprietary products.
• Demonstrate initiative in idea generation, experimental design, and understanding of literature and interpretation of results.  Develop experimental ideas, write reports with minimal consultation.
• Be capable of performing tasks with a focus on Oral formulation, OCR & conventional solid dosage forms with the following processes, as applicable to ongoing projects: Granulation, Tabletting, IR/SR Bead Manufacture, Coating, encapsulation, etc.
• Continue to develop knowledge in relevant subject areas and expand breadth of knowledge, including areas outside of direct function, with a view to transferring to others.
• Identify and implement formulation development / optimisation programmes with clear objectives for the relevant projects for approval by Senior Management, participate actively in relevant project team meetings, providing consultation and leadership to teams and act as a role model for high standards of performance.  Involved in training of inexperienced personnel in theoretical and practical aspects of standard and non-standard procedures / approaches, acquire/develop new formulation approaches in line with project requirements.
• Be capable of performing to a high quality, the following as applicable to project work: interpret formulation, analytical, bioanalytical data and provide trouble-shooting input on a formulation level and a processing level.
• Execute technical work to a high standard, as appropriate, to relevant projects using standard procedures and non-standard procedures of some complexity.
• Develop and evaluate systems to optimise formulation processes.
• Demonstrate ongoing familiarity with literature and incorporate observations/information into formulation programmes.
• Utilise data from literature surveys on a regular basis to support experimental / developmental work.
• Comply with all aspects of cGMP, Safety and Environmental regulations and Company policies, which impacts on doing the job.
• Work as a team member and take on leadership opportunities to actively participate in achieving the aims and goals of the project team.
• Communicate issues, data and resolution ideas within R&D in a timely manner to permit objectives to be met and to confirm solutions to problems with Senior Management. Highlight critical issues promptly.
• Prepare timely, concise and accurate reports on work performed and outlining plans for future work.
• Prepare and present presentations internally and externally.

• Minimum of a scientific Bachelor's degree (Chemistry/Physics/Formulation Chemistry, Industrial Chemistry/Pharmaceutical sciences/Pharmacy) and a minimum of 12 years of relevant experienceOR withaM.Sc. with a minimum of 8 yearsOR with a PhD with a minimum of five years relevant industrial experience. However, a combination of experience and/or education will be taken into consideration.
• Experience in solid oral dosage forms is essential.  Experience in OCR is a plus.
• Experience in physical chemistry techniques and applications and material science is a plus.
• Proactive, innovative with good problem solving skills.
• Excellent interpersonal, leadership, collaborative, communication (written and verbal) and time-management skills are essential.
• Proven track record in current and previous roles.
• Results and Performance driven.
• Strong leadership skills and ability to work within cross-functional teams.  Experience leading technical teams is a plus.
• Capable of working in a team structure.

• People management - supervision of the warehouse team to ensure that all customer (both internal and external) metrics are serviced in line with expectations. This will be achieved through the application of an empowering style of leadership which draws fully on resources and capabilities of the team coupled with a positive Employee Relations approach. Essentially this will embrace the following :
• Providing timely feedback and review, and ensuring all performance issues are dealt with in a constructive and prompt manner.
• Ensuring that all employees are treated with the fairness and respect due to them.
• Facilitating open two-way communications regarding individual, team and company performance through weekly team meetings and daily interaction on the line.
• Liaising with line trainer to develop a training program to ensure smooth operation of department, development of product builders, health & safety of personnel.
• Through policy and procedure improvement/changes, develop inventory processes to minimise risk and improve compliance in the warehouse.
• Maintaining Good Manufacturing Practises / Housekeeping at a high level within the department through the involvement of all team members.
• Cross-functional management of QA, materials, IS and HR support for the team.
• Interacting and liaising with the other manufacturing teams and Demand planning to prioritise backorders.
• Managing process and material flows, space management, to maximise utilisation of the warehouse.
• Administration duties which include Time and Attendance system, Holiday planning, Build Plan review Back Order review, Travel planning etc.
• Establish and support a work environment of continuous improvement that supports our client’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.

• Bachelor of Science / Engineering or relevant qualification
• 5 years logistics/distribution/warehouse experience at a supervisory level essential within a manufacturing environment
• Expert knowledge of shipping and freight procedures
• Knowledge of import/export procedures
• Knowledge of SAP system an advantage
• Good knowledge of Good Manufacturing Processes /FDA regulatory requirements, housekeeping, health and safety.
• Excellent interpersonal and communication skills
• Solid record of attention to detail and strict adherence to procedures
• Previous experience or working knowledge of Lean manufacturing would be an distinct advantage
• Previous knowledge of manufacturing and process improvement techniques such as Kaizen, would be a distinct advantage.

• Providing technical leadership on product and process issues.
• Leading technical improvement under the team’s VIP program.
• Transferring and implementing processes either from development or from another manufacturing facility.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Participation, where appropriate, in the phase review process and the NPE meetings with respect to new products.
• On-going manufacturing support in order to help the team meet its business objectives of quality, output and cost.
• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital.
• Provide technical leadership/guidance for the Process Technician on the team (with specific responsibility to ensure that the preventative maintenance program is adequate and timely).
• Development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
• Project planning, in detail, in support of major projects, product/process transfer etc
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Responsible for other projects as assigned by the company.
• Demonstrate a primary commitment to patient safety and product quality.
• Understands and comply with all the regulations governing the quality systems
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

• Bachelor of Engineering (HETAC level 8)
• Minimum of 8 years of professional experience in successfully managing projects and leading teams.
• Strong technical capabilities, technical management skills communication skills, teamwork abilities and initiative.
• Knowledgeable in Six Sigma tools and methodologies

• The role will provide direction and support to MTC’s (Manufacturing Training Co-ordinators) to ensure the following:
• Setting standards, ensuring quality and consistency of training delivered by SMEs is maintained.
• Benchmarking  ie system updates, training standards updates.
• Drive a culture that supports Defect Awareness.
• Build a process for the verification of effectiveness of training.
• Escalation point for Training Process Changes, and it’s possible impact on Production Organisation.
• Guidance to MTC Team on the relevant change management.
• Participation and support of  Lean Business Process Improvements.
• Provide training and re-certification programs for MTC’s.
• Work with the business to create Technical Training Plans.
• Develop a framework that supports the organisation’s Technical Training Requirements supporting all operational functions.
• Drive a culture of evaluation and effectiveness of Training
• Provide training and development for SME’s – ie Train the Trainer.
• Develop Subject Matter Experts (SMEs) to support the development & implementation of the Role based training plans.
• Drive the ‘Role-based model’ for SLMS Training.
• Create metrics as leading indicators for training.
• Ensure that Training Procedures are developed are in compliance with FDA QSRs & ISO requirements.
• Provide training event management ie logistics, planning, rollout and records to support the cross functional needs.

• Administration / Business Degree essential. Completion of an external Quality Assurance related course desirable.
• Minimum of  3 – 5 years experience in a HR , Engineering or Production  role within a high volume manufacturing environment an advantage.
• 3 – 5 years experience within a medical device environment an advantage.
• Excellent computer skills is a requirement, must be capable of working accross multiple systems.
• Communicates and influences at different forums, functions and levels within the local Ireland sites and in Divisional/ Corporate arenas.
• Builds strong relationships by fostering open communications, respect and trust.
• Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
• Builds strong customer engagement and credibility by delivering on expectations and commitments.
• Excellent project management capabilities: plans, prioritizes and organizes multiple concurrent tasks are completed to the highest standard whilst meeting  deadlines.
• Strong Team player who effectively utilises individual strengths and talents to maximise team services to customers.
• Focuses on achievement of team objectives and team success.
• Ability to generate plans and multiple events, explain detailed training requirements.

• Responsible for providing HR leadership and team direction in most of the following areas: competency development, succession planning, talent management, talent acquisition, labour relations, employment law compliance, employee relations, employee engagement, change management and process improvement.
• Coach and consult with management on issues affecting morale, performance, development and organization effectiveness, helping to determine root causes and recommending appropriate next steps.
• Provide guidance and direction to client group(s) to ensure consistent, equal and fair treatment of all employees. Consult with managers to ensure the consistent application of and adherence to company policies and procedures.
• Partner with HR Centers of Excellence to address and satisfy client group(s) requirements.
• Apply knowledge of key business drivers in making decisions related to human capital.
• Present, train and/or facilitate workforce development programs. Support communication on and utilization of performance management tools & processes and compensation & rewards programs.
• Introduce, lead and influence change management initiatives with client group leaders in order to address issues that will enhance overall performance and build the over all human capital capability of the organization.
• Conduct and manage investigation of complaints and concerns that could result in legal ramifications; assess the severity, involve appropriate individuals and facilitate appropriate action based on policy and practice.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools etc.) are maintained in order to assure Quality System compliance and adherence to our clients Quality policy.
• Establishes and promotes a work environment that supports the Quality policy and Quality System.

• May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct and develop reports, and if applicable, drive those practices throughout their organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• May direct and control the activities and budget of one or more functional areas, divisions, product groups, project/program and/or operations.
• Monitor and ensure compliance with company policies and procedures (e.g. federal /country and regulatory requirements).

• Accomplishes results through professional specialist employees or subordinate managers and supervisors who exercise significant latitude and independence in their assignments. Provide directions and monitors progress toward department goals; monitors costs of projects and of human and material resources within a department or unit; monitors company-wide indicators such as market share and profitability; monitors external environment in area of technical or professional responsibility. Subject to approval, modifies the organisational structure of centralized functions and units. Often responsible for managing a staff function of the company.

• Honours Degree in Human Resource Management, CIPD Member
• 10 years of related work experience
• Demonstrated coaching and facilitating competencies required
• Senior leadership team role
• Ops/eng background would be preferable
• Experienced in actively managing and embedding vision, values and leadership style in the cultural context is required

• Financial Reporting, monthly Profit & Loss and Balance Sheet under US GAAP, related financial analysis (taxation, treasury, balance sheet etc), reconciliation of US GAAP to local Statutory book, ad hoc reporting / corporate analysis requests, maintenance & development of the Hyperion reporting software.
• Preparation of Statutory Accounts for Irish registered entities, incorporating all new developments in Irish GAAP where necessary
• Project Work; ad hoc project management & implementation as required (e.g. Value improvement projects, system upgrades & developments, continuous automation).
• External statutory reporting requirements, including CSO, IDA etc.
• Other – cashflow forecasting, maintenance & accounting for transfer pricing structure, inter company activity, treasury & netting, liaison with internal and external auditors, assist in the development and implementation of local accounting controls in line with SOX requirements
• To build quality into all aspects of work by maintaining compliance to all quality requirements

• A recognized accounting qualification (ACA, ACCA) obtained through working within a medium to large accounting practice.
• Highly motivated & energetic person who can work on own initiative and add value to the accounting team

• Administer the daily inputting of ILT (Instructor led training) classes/credits into our client’s training system for all Operations on-the-job Training and Class room based training.
• Record Management and off site storage / scanning.
• Implement Change requests / Add retire (local curriculums and User groups only)
• Support daily Service Now Tickets.
• Management of Absences
• Support New Hire Induction Program
• Train new employees on our client’s training system.
• Supports record management for all training events based in the organisation.
• Run Audit reports in support of site audits.
• Compile Reports for Compliance PTQ Metric

• High level of PC skills required must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Skilled in Adobe Articulate and Captivate an advantage.
• Attention to detail – work requires careful application and attention to detail, with thoroughness in completing lengthy work tasks.
• A self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Capable of working as part of a multi-disciplined team.
• Highly organized and disciplined and be able to demonstrate their ability to meet deadlines.
• Excellent communication and presentation skills.
• Full understanding of the Quality Management System or equivalent and be proficient and capable of becoming a Super User of the Learning Management System.
• External Accreditation in Business Administration or equivalent
• Experience in a Learning Management System is an advantage.
• Minimum of 3 years a high volume manufacturing environment an advantage.

• Environmental Health & Safety of manufacturing personnel, ensuring
  that all employees are adequately trained, aware of, and complying with EHS procedures
• To continuously improve the performance of the business unit.
• Engage and participate on delivery of all the BU KPI’s
• Promote and be a key stakeholder of lean manufacture and visual management within the production environment and its implementation.
• Core Time and Attendance System.
• Ensure that Quality standards are achieved and maintained in the manufacturing areas.
• Expediting production, maximising efficiencies and meeting KPI’s
• Provide direction and support to manufacturing team members.
• Communicate & keep team updated on all matters relevant to the business and cell in a timely and appropriate means.
• Ensure that training happens according to the process instructions and that skill versatility targets are met and maintained.
• Provide production plan updating for daily production meetings.
• Ensure that employees are aware of and comply with all company policies and procedures across all shift patterns.
• Maximise efficiencies and performance across all manufacturing areas.
• Ensure that good housekeeping is maintained in compliance with the 5 Pillars Program
• Liaise with the Warehouse and Distribution to ensure material is transacted correctly and on time.
• Establish and encourage a strong teamwork culture within the cell.
• Co-ordinate shift handovers.
• Lead and participate in cross-functional and cross-divisional process improvement initiatives

• A minimum of 4/5 years supervisory/people management experience in a high volume manufacturing environment is desirable.
• Third level technical qualification or extensive experience in a technical environment an advantage
• Production process troubleshooting experience required.
• Dynamic “hands-on” individual prepared to take responsibility.
• Excellent communication and interpersonal skills.
• Knowledge of ISO/QS9000 and FDA Quality standards.
• Good working knowledge of MRP.
• High level of PC skills required.
• Excellent communication skills.
• Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Capable of working as part of a multi-disciplined team.

• Partner with Advanced process technology development group within R&D to ensure the best in class suppliers are considered and chosen during the development process.
• Partner with Advanced Operations to Investigate, analyze and evaluate new suppliers needed to meet New Product Pipeline requirements when core competency does not exist internally or as part of global strategic supply base.
• Become supplier capability subject matter expert to support new technology and new product development pipeline.
• Support Operations build plan goals through assurance of supply after new product launch by performing capability analysis of suppliers prior to making sourcing decisions.
• Support development of cost models in order to inform the Make vs. Buy process and sourcing decisions.
• Support RFQ creation process for New Products.
• Partner with Advanced Operations in the Make vs Buy process and ensure for ‘buy’ decisions that the optimal manufacturing process at our strategic supply base and location is selected to provide the highest quality at optimum cost.
• Partner with Advanced Operations to support R&D and Marketing team goals by providing innovative solutions, attaining project timeline milestones, and executing flawless new product launch at suppliers.
• Minimize new product cost by simplifying the supply chain and improving operational efficiency and purchasing processes
• Partner with suppliers and Advanced Operations to ensure the latest technological innovations are available to be incorporated into our product and process designs.
• Develop cost models to inform the Make vs. Buy process and sourcing decisions.
• Partner with Advanced Operations in the Make vs Buy process and ensure for ‘buy’ decisions that the optimal manufacturing process at our strategic supply base and location is selected to provide the highest quality at optimum cost.
• Build trusting relationships with suppliers to facilitate partnerships and knowledge sharing.
• Participate in Process Design Reviews when necessary.
• Support product cost reduction and continuous improvement initiatives with new suppliers

• A Masters Degree in an engineering or business discipline. Candidates with a bachelor’s degree in a technical discipline and significant relevant experience will be considered.
• 6+ years experience in supplier development, process development or related discipline.
• Demonstrated quantitative and analytical abilities.
• Demonstrated knowledge of procurement strategy and market drivers.
• Demonstrated knowledge and experience in contractual negotiations.
• Strategic thinker: ability to see the big picture and translate this into operational objectives.
• Ability to plan, organise, and implement multiple concurrent tasks.
• Excellent problem solving skills.
• Effective interpersonal, communication and presentation skills with an ability to overcome language, cultural barriers and to manage conflict and ambiguity.
• Demonstrated leadership, customer service, problem solving, communication, negotiation, tact, judgment, and organizational skills.
• Strong project management capabilities with the ability to lead and support several concurrent projects and develop strong relationship within cross-functional teams.
• Previous experience in a variety of manufacturing processes.
• Develops self and others, by building on strengths and addressing weaknesses. Seeks feedback and is receptive to new ideas and perspectives.
• Ability to influence others through presentation of facts, analysis and conclusions or solutions in a manner that demonstrates command of the content.
• Must be willing to travel as required to support supplier search, assessment and support activity - at least 40%.
• Must be able to generate, follow and explain detailed quality requirements and inspection procedures.
• International experience through work placement or working with suppliers over an extended period is preferred.
• Experience in a regulated environment desired but not essential

• Advanced working knowledge of Microsoft Office Suite (Word, Excel, Visio, PowerPoint)
• Working knowledge of SharePoint, Adobe Acrobat, and internet tools.
• Experience with computer-based project management tools such as Microsoft Project.
• Ability to understand and interpret complicated design prints and GD&T.
• Broad and in-depth knowledge of good manufacturing practices and industry standards.
• Experience in negotiations with suppliers and in financial analysis desired.
• Demonstrated financial analysis capability

• Ensure quality of process and product as defined in appropriate OS and Material specifications.
• Ensure GMPs and system safety and promotes compliance.
• Engage and participate on the delivery of the BU KPI’s
• Continuously improve the performance of the business unit.
• Provide leadership and direction to the BU on technology development and application within the manufacturing process.
• Engage in the implementation of lean manufacture within the BU.
• Participate in FMEA and PPAP activities associated with product transfers and launches
• Support all capital acquisition activity from specifying equipment, contract negotiation, Installation and validation
• Train manufacturing team members.
• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
• Validation, Appraisal and support of coating suppliers, machining suppliers and raw material suppliers e.g. Forgings, titanium etc.
• Support process development and cost reduction activities within the business units
• Communicate and participate in system and process troubleshooting with support team members and with external agents.
• Lead and participate in cross-functional and cross divisional process improvement initiatives.

• Degree in Mechanical Engineering or equivalent is required.
• The individual must have a minimum of 2 years’ experience in an engineering role within a CNC environment.
• Business understanding of operations and there impacts essential.
• High level of PC Skills required.
• Flexibility essential.
• Strong communication skills with both Internal and external agents.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
• Capable of working as part of a multi-disciplined team
• Competent in preparing and implementing technology improvement strategy.

• To support the key activities utilized in quality, service & cost improvements in the Operations Engineering Cycle to meet key business objectives.
• To support a prioritised approach in Value Centred Engineering to achieve the key opportunities in quality, service and cost.
• Daily production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls.
• Provision of technical support on maintenance and equipment issues.
  Provision of technical guidance for the Process and Maintenance Technicians on the team.
• Regular communication with the Product Builders regarding issues, concerns and watch-outs on the lines.
• Liaising with the Quality and Operations functions in pursuit of achieving the quality and S&OP targets for each given area.
• Participation in cross-functional projects works as dictated by the emerging business needs.
• Taking direction from Manufacturing Engineer II’s and Senior Engineer’s as to how best to deploy resources and effort on the operations floor.
• Actively seek ways and means of increasing efficiency, productivity, yield and space utilisation on the operations floor.
• Manage material risks, as identified by the business
• Observe the Quality Management Systems requirements on site at all times
• Work closely with approved Equipment Design & Engineering workshops in getting equipment/fixtures designed & fabricated.
• Development and implementation of appropriate supporting documentation which complies with Good Manufacturing Practices (GMP) in conjunction with other team members.
• Leading technical improvements under the site’s continuous improvement program.
• Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets
• Fostering a work environment of continuous improvement that supports our client’s Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented.
• Observing the Quality Management Systems requirements on site at all times

• Preferably Degree qualified in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc.) with 0 - 2.5 year’s relevant experience.
• Demonstrable analytical & problem solving skills, and the ability to handle multiple tasks in a fast-paced and results-oriented environment. Experience/training in problem solving methodology would be a distinct advantage
• Excellent presentation and written / verbal communication skills
• An ability to work autonomously
  A team player, with a flexible approach.
  Experience in the medical device industry is an advantage.
  There may be a requirement as part of the role to travel to other sites

• Ensure quality of process and product as defined in appropriate OS and Material specifications.
• Ensure GMPs and system safety and promotes compliance.
• Engage and participate on the delivery of the BU KPI’s
• Continuously improve the performance of the business unit.
• Provide leadership and direction to the BU on technology development and application within the manufacturing process.
• Engage in the implementation of lean manufacture within the BU.
• Participate in FMEA and PPAP activities associated with product transfers and launches
• Support all capital acquisition activity from specifying equipment, contract negotiation, Installation and validation
• Train manufacturing team members.
• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
• Validation, Appraisal and support of coating suppliers, machining suppliers and raw material suppliers e.g. Forgings, titanium etc.
• Support process development and cost reduction activities within the business units
• Communicate and participate in system and process troubleshooting with support team members and with external agents.
• Lead and participate in cross-functional and cross divisional process improvement initiatives.

• Degree in Mechanical Engineering or equivalent is required.
• The individual must have a minimum of 2 years’ experience in an engineering role within a CNC environment.
• Business understanding of operations and there impacts essential.
• High level of PC Skills required.
• Flexibility essential.
• Strong communication skills with both Internal and external agents.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
• Capable of working as part of a multi-disciplined team
• Competent in preparing and implementing technology improvement strategy.

• To identify and order the key activities utilized in quality, service & cost improvements in the Operations Engineering Cycle to meet key business objectives.
• To apply a prioritised approach in Value Centred Engineering to achieve the key opportunities in quality, service and cost.
• Providing technical leadership on all product and process issues.
• Line performance monitoring and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Development and implementation of appropriate supporting documentation, and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Leading technical improvement under the team’s Continuous Improvement Program (CIP).
• Transferring and implementing processes either from development or from another manufacturing facility.
• Participation, where appropriate, in the phase review process with respect to new products.
• Provide technical leadership/guidance for the Process Technicians and Manufacturing Engineers I’s on the team.
• Project planning, in detail, in support of major projects, product/process transfer etc.
• Responsible for other projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and handover as appropriate. Observance of the site Equipment and Automated Systems (E&AS) procedures for new equipment.
• Establish and support a work environment of continuous improvement that supports our client’s Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure employees are trained to do their work and their training is documented.
• Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around same.
• Cross functional liaison with support functions in pursuit support for achieving the business targets
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• Observe the Quality Management Systems requirements on site at all times
• Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers.

• Degree or Masters in relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc) with a minimum of 2 years relevant experience and ideally 4/5 years’ experience.
• Project Management skills would be a distinct advantage.
• Strong leadership skills and the ability to make effective decisions.
• Excellent problem solver.
• Excellent communications ability
• Demonstrable ability to work autonomously
• Technological pioneer, willing to source, investigate and implement technological and automation advances on the floor
• Experience/training in problem solving and process improvement methodologies. (Engineering Essentials TM)

• Ensure quality of process and product as defined in appropriate OS and Material specifications.
• Ensure GMPs and system safety and promotes compliance.
• Engage and participate on the delivery of the BU KPI’s
• Provide leadership and direction to the BU on technology development and application within the manufacturing process.
• Engage in the implementation of lean manufacturing.
• Participate in FMEA and PPAP activities associated with product transfers and launches
• Support all capital acquisition activity from sourcing, specifying equipment, contract negotiation, Installation, validation nad subsequent production support.
• Train manufacturing team members.
• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
• Support process development and cost reduction activities within the packaging business units.
• Communicate and participate in system and process troubleshooting with support team members and with external agents.
• Lead and participate in cross-functional and cross divisional process improvement initiatives

• Degree in Mechanical Engineering or equivalent is required.
• The individual must have a minimum of 2 years’ experience in an engineering role within regulated environment.
• Business understanding of operations and there impacts essential.
• High level of PC Skills required.
• Flexibility essential.
• Strong communication skills with both Internal and external agents.
• Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
• Capable of working as part of a multi-disciplined team
• Competent in preparing and implementing technology improvement strategy

• Support employees and act as a trusted advisor/partner to managers on people related and HR issues.
• Ensure compliance with employment legislation and that HR policies and procedures respond to evolving government regulations & corporate policy.
• Maintain accurate contracts of employment and oversee changes to employment terms according to changing legislation & best practice.
• Keep compensation and benefits in line with industry benchmarks & ensure tax compliance for various staff located outside of Ireland.
• Co-ordinate the salary review process and develop a relevant performance management system.
• Partner with all key business stakeholders to align HR activities to the changing needs of the business & retain high potential employees.
• Oversee Talent Management Plan adopted by the company and expand plan in line with company direction.
• Develop and implement a HR Plan for the business in co-operation with senior managers.
• Manage HR staff (x1 direct) and ensure HR–related administration is kept up-to-date and accurate.
• Support Health & Safety Officer for the Galway sites.

• Strategically support the Getting to Growth Plan of the company and advise, where appropriate and support the work necessary to move the strategic projects along.
• Manage the communications plan for the company including the Quarterly Company communications meetings, the departmental meetings and group coffee meetings monthly in support of Operations Manager.
• Manage and influence the phased Talent Management Plan for company and expand knowledge of the needs of company to support a Talent Management plan with the management team and further on an on-going basis.
• Manage Integrated Training Plan for all employees taking a basic training needs analysis to a full integrated training plan per person considering Operations, Quality and softer skills training for all. This project is in the early phase and requires someone to develop it further to fully integrate all of the developmental needs of the employee base.
• Support Strategic KPI’s and initiate/support/develop the key metrics and KPI’s of the HR department in line with best practice
• Influence Health and Safety to appropriate level on on-going projects

• Responsible for Manufacturing Engineering of a given area.
• Works with Value Stream and Quality Engineering Manager to deliver business objectives – lean manufacturing metrics, VIP, cycle time, scarp as %VOP etc.
• Responsible for developing a world class-manufacturing group that is proficient in problem solving manufacturing issues using Six-Sigma tools.
• Drives IBP (Integrated Business Plan) contract deliverables by providing input on process technology selection.
• Develops and executes departmental budgets and capital spending.
• Leads or represents function in periodic business metric reviews.
• Initiates cross-functional partnerships to identify and resolve production/engineering issues.
• Prioritizes and drives execution of multiple complex department projects. Sponsors and supports Operations Value Improvement Process (VIP) or Strategic Activity Review (STAR) projects.
• Responsible for the departmental basics including budgeting, hiring, day-to-day management, project resourcing, etc.
• Establishes and supports a work environment of continuous improvement that supports our client’s Quality policy, Quality System & the appropriate regulations for the area.
• Ensures employees are trained to do their work and their training is documented.
• Maintain compliance metrics around adherence to preventative maintenance schedule and calibration schedule.
• Ensure relevant documentation is prepared and updated in line with all Quality and Regulatory guidelines and promotes full compliance to all GMP & E&AS requirements.
• Keep abreast of all relevant technological advancements.
• Maintain and develop the team’s technical and trouble shooting skills.
• Sustain an environment of continuous improvement.
• Develop and maintain relationships with technical management in sister sites and R&D.
• Develop new equipment/processes as necessary.
• Develop and implement the appropriate maintenance procedures and protocols to ensure processes remain in control at all times.
• Oversee the specification and purchase of capital equipment ensuring balance between optimizing technological capabilities and return on investment.
• Manage the planning and execution of equipment validations per E&AS requirements.

• BS in Engineering (mechanical, polymer or chemical), with a Masters degree a distinct advantage.
• A minimum of 9 years of technical/professional experience.
• A minimum of 5 years people management experience in a manufacturing environment.
• Minimum of Bachelor of Science Degree in Science/Engineering/Technology or suitable equivalent.
• Experience in the medical device industry is an advantage.
• Experience/training in problem solving and process improvement methodologies.

• To support the key activities utilized in quality, service & cost improvements in the Operations Engineering Cycle to meet key business objectives
• To support a prioritised approach in Value Centred Engineering to achieve the key opportunities in quality, service and cost
• Production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls
• Liaising with the Quality and Operations functions in pursuit of achieving the quality and S&OP targets for each given area
• Participation in cross-functional projects works as dictated by the emerging business needs
• Taking direction from Manufacturing Engineer II’s and Senior Engineer’s as to how best to deploy resources and effort on the operations floor.
• Actively seek ways and means of increasing efficiency, productivity, yield and space utilisation on the operations floor.
• Manage material risks, as identified by the business
• Observe the Quality Management Systems requirements on site at all times
• Communicate regularly with the Product Builders regarding issues, concerns and watch-outs on the lines.
• Work closely with our in-house Equipment Design & Engineering workshop in getting equipment / fixtures designed & fabricated
• Development and implementation of appropriate supporting documentation which complies with Good Manufacturing Practices (GMP) in conjunction with other team members
• Leading technical improvements under the site’s continuous improvement program
• Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements
• Adherence to and enforcement of all Environmental Health & Safety (EHS) requirements on site

• Technical Degree, Honours Degree Level 8 on NFQ, qualified in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc.).
• Previous experience in medical device manufacturing (ideally 2 - 3 year’s advantageous).
• Experience with FMEA’s, validations and problem solving toolkits desirable

• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.  Prepares reports, publishes, and makes presentations to communicate findings.
• Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Providing professional and technical leadership to Manufacturing Engineers and Process technicians on product and process issues.
• Understands engineering principles theories, concepts, practices and techniques.  Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.
• Incorporates business policies and procedures into task completion.  Understands the business needs of the company, and has knowledge of the customer needs of our business.  Understands the business cycle and foresight of emerging technologies trends.
• Cultivates internal and external network of resources to complete tasks.  Serves has a resource in the selection orientation and training of new engineers and employees.  May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.
• Interacts cross functionally and with internal and external customers.  Serves as a consultant for engineering or scientific interpretations and advice on significant matters.  Acts as a spokesperson to customers on business unit current and future capabilities.

• Degree in relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc).
• Minimum of 5+ years experience preferably in the medical device industry.
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Strong technical capabilities and project management capability to develop aspect of assigned projects on time and within budget.
• Experience/training in problem solving and process improvement methodologies

• Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
• Participates in the Material Review Board (MRB) decision process.
• Identifies and implements corrective actions for manufacturing related issues.
• Performs equipment setup and corrective, preventive and calibration maintenance as necessary.
• Installs and validates equipments and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
• Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
• Certifies manufacturing associates in the production processes.
• Evaluates and orders necessary equipment, tools and fixtures.

• Electrical Fault finding/equipment fault finding advantageous
• NCEA Certificate / Diploma in Mechanical / Production / Manufacturing / Mechatronics Engineering and / or Senior Trades.
• Electrical Fault finding/equipment fault finding advantageous
• Proven experience in process improvements including computer aided tooling / fixture design, build and implementation.
• Ability to work on own with minimum supervision.
• Good interpersonal and communication skills.

• Supervision of Quality Technicians.
• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

• Ideally will possess Bachelor of Science Degree in Engineering/Technology.
• 3/4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 desirable.
• Experience of Internal Audits and CAPA’s desirable.
• Excellent interpersonal and communication skills.
• Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
• Experience/training in problem solving and process improvement methodologies.

• Helpdesk Management – To provide IT System support to all our internal customers. To ensure all requests are recorded & resolved in a timely manner, and users are kept informed of progress and completion.
• Install, maintain and Troubleshoot PC’s, printers and peripherals.
• Anti Virus and WUS Management, Backup and Restore Management
• Vendor management & annual maintenance agreements
• Procurement of Hardware / Software
• System Administration and Maintenance for Windows Server Platform, MS Exchange & AS400
• Network Administration for Cisco Routers & Switches
• Phone System Administration

• Self motivated with a high level of initiative and attention to detail
• Team Player with excellent interpersonal skills
• Excellent time management skills and ability to prioritise workload
• Project management experience an advantage
• Three/Four year’s experience in the IT area
• Microsoft Windows Server & Exchange experience
• Knowledge of HP/Dell Hardware
• Unix/AS400 experience
• Micro soft Office suite
• HP-SAN and VM-Ware experience an advantage
• Graduate in Software Engineering or Computer Systems, or 5yrs experience in a similar role

• Supervision of Quality Technicians.
• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (E.g. Use of DOE studies, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV)
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements)
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements

• Ideally will possess Bachelor of Science Degree in Engineering/Technology.
• 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 desirable.
• Excellent interpersonal and communication skills.
• Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
• Experience/training in problem solving and process improvement methodologies

• Timely implementation of new manufacturing processes in the designated Value Stream area.
• Projects will include Capacity, New Products, and Cost Reduction, and will involve highly automated production equipment. Position will provide leadership of cross functional team to deliver on same objectives.
• Scope would include: User Requirements (URS), Functional Design Specifications (FDS), Capital Approval, conducting Design reviews (FMEA tools).
• Will be responsible for developing, tracking & communicating project plans, as well as maintaining project budgetary control.
• Must identify and implementing process & product improvements in the area.
• Drive & /or support timely introduction on new products or product upgrades in the designated Value Stream area.
• Support qualification of new products / processes, and ensure compliance to quality standards through execution of protocols.
• Ensure safety compliance in the area, and supporting both conduction and timely closeout of risk assessments
• Technically lead a cross-functional team to ensure delivery of all relevant performance metrics within Value stream.
• Also some travel: 15% (may increase due to project work).

• Primary Degree in Engineering discipline, preferably Mechanical or Plastics Engineering or equivalent Project Management Training/Qualification.
• 5+ years post qualification experience in general project engineering, with a focus on mechanical systems & their application in a manufacturing environment (batch type process for the medical devices / healthcare / pharmaceutical/ air motive industry preferred).
• Process back ground desirable with medical, healthcare or plastics experience.
• 2D/3D CAD skills (AutoCAD or equivalent).
• Pneumatic Circuits & Controls.
• High volume, automated manufacturing systems.
• PLC controls .
• Occupational Health and Safety.
• Plastic Welding Heat Seal Technology (Thermal/ Impulse).
• Plastic Part assembly and Servo Control systems.

• Oversees the planning, design, reconfiguration, maintenance, and alteration of equipment, machinery, buildings, structures, and other facilities
• Responsible for planning plant, office and production equipment layouts for economy of operation and maximum utilization of facilities and equipment
• Responsible for some contractor management including supervising and scheduling the work of some non-employees (contractor) groups in one or more areas within the site services function; including contract catering, security, cleaning & gowning, site construction and repair, grounds maintenance and leading a team of internal maintenance support technicians
• Works off own initiative to resolve engineering, systems, contractor and vendor challenges through problem solving techniques, recommending and implementing solutions
• Reviews and estimates design costs including equipment, installation, labor, materials, preparation, and other related costs
• Develops criteria and performance specifications for facilities and equipment required to meet unique operating requirements and building and safety codes
• Coordinates with architecture/engineering in developing design criteria and preparing layout and detail drawings
• Gathers and reviews data concerning facility or equipment specifications
• Assists in development and maintenance of short-term and long-term facilities space plan
• May be responsible for scheduling, coordinating, and planning preventative maintenance

• Honours Degree (Level 8 on NFQ) Mechanical, Manufacturing or a relevant field of study
• 5+ years experience in Facilities/Site Services preferably in a regulated manufacturing environment
• Strong technical knowledge of building services; including building management and HVAC systems is essential
• Strong Project Management skills from day to day low level projects to large capital projects is essential
• Experience of delivering efficiency improvement projects; budgeting, cost control, resource utilisation etc.
• Experience in calibration and validation advantageous
• Familiarity with building contracts, service contracts and service level agreements advantageous

• Development of medical device products from concept to production. Participation in multifunctional product development teams and liaison with marketing for the development and specification of new concepts for medical device products.
• You will work with a highly creative design team to invent and develop innovative new product concepts.  Create smart, innovative solutions to mechanical design challenges. Conceive plans and conducts research in problem areas of considerable scope and complexity.
• Evaluate and optimize concepts for mechanical function and manufacturability. Develop product designs and create prototypes from customer concepts and/or specs to test and validate ideas
• Will determine and implement design approaches and parameters and conduct feasibility studies on new designs. Will analyze equipment to establish operating data, conduct experimental tests and evaluate the results. Lead and/or participate in design and review meetings.
• Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with advanced quality engineers to develop component specific testing and inspection protocols.
• Liaison with advanced manufacturing engineers and supply chain personnel for the specification and sourcing of raw materials and suppliers.
• Communicate with suppliers and advanced operations to resolve issues and optimize design for manufacturability and efficiency. Will ensure designs are cost efficient, manufacturable and reliable.
• You will lead and contribute significantly in efforts to identify, determine product requirements, generate production drawings for parts and assemblies and develop and manage full product design documentation
• This position is accountable for achieving product performance and quality objectives, project planning and effective execution, as well as communicating program status and escalating issues when appropriate. Will coordinate procedures, timeframes, and in process testing with manufacturing sites.
• Will assist end customers in resolving product related issues.Problem solving and troubleshoot product designs Product training. Product design and development

• Bachelor Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Electrical Engineering or Materials Science).
• A Masters degree or PhD in an engineering field is desirable.
• Minimum of 5 years related medical device or mechanical design experience in a face paced high technology environment.
• Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.  Open minded- able to recognize good ideas
• Innovative thinker - able to envision new and better ways to do things
• Experience in executing complex problem solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
• Good understanding of design for six sigma and related statistical tools and validation/verification techniques.
• Excellent analytical skills, ability to plan, organize, and implement multiple concurrent tasks.
• Must be able to analyze and correct complex product and/or process issues and make decisions using independent judgement
• Ideally has good working knowledge of anatomy and Orthopaedic/Neuro surgical procedures.
• Good working knowledge of CAD/CAM/CAE computer systems, engineering materials and design, coating technologies, plastic part design and advanced manufacturing technologies. Fluent in Pro Engineer with good working knowledge of Finite Element Analysis tools.
• Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
• Must have the ability to work with and assemble small objects and component parts. Ability to operate small hand tools and inspection equipment
• Must be able to generate, follow and explain detailed proposals and operating procedures with an in depth understanding of ISO 13485 and FDA quality system requirements
• PC Literate (word processing, spreadsheets, data base) and strong knowledge of project Management tools is essential

• To provide leadership and strategic direction to the company’s financial and business related affairs
• Formulation and development of financial policies and systems which can significantly enhance organisational performance and profitability
• Work with site leadership team and corporate peer group on financial modelling, budgeting and new product analysis initiatives
• Support the development and execution of the strategic plan, through scenario planning and cost management for new product development and introduction projects
• Manages improvement of financial processes such as systems implementations, ensuring such systems support analytical, structured and controlled business practices
• Manage site forecasting and planning processes including rolling forecasts of income statements, headcount and capital planning and a very substantial inventory operation
• Budgetary preparation and control and continued implementation of sound financial forecasting processes
• Provide financial leadership Business Partner support and to function heads, international peers and business unit leaders.  
• Execute world class functional leadership to the Finance team
• Keeps the organization's vision and values at the forefront of decision-making and demonstrate effective change leadership

• Serious candidates for the position must have a background of solid, creative and senior management experience in a large international organisation. Candidates will also display clear leadership qualities and performance management skills.   
• A third level degree and professional accounting accreditation (ACA, ACCA, CIMA).   An additional post graduate qualification such as an MBA is an advantage
• At least 10 years post qualification experience in financial management, 3 years at Finance Manager with a demonstrable track record at Head of Function level
• Proven track record in large, complex and demanding multinational entities
• Clearly demonstrated ability to lead an established Finance team

• As a member of the technical team on site the Moulding Engineer is expected to build and maintain excellent working relationships with all team members.
• Actively interfacing with cross?functional team members, always practicing good team work in support of day to day operating requirements.
• Works with the Production Team Leaders and technicians in troubleshooting processing problems
• Continually monitor and achieve set goals and targets. (Yield, Downtime, OEE)
• Work with internal and external resources to identify and put in place permanent and effective technical / system solutions to problems.
• Be capable of working and building relationships with sister sites, recommending improvements to tool design, set up and overall manufacturing
• Provide input on new or alternate materials for cost reduction or molding improvements.
• Consistently meet customer requirements and commitment to excellence in performance and meeting deadlines.
• Maximise output through technical solutions that increase efficiencies and implement cost reduction initiatives within the process.
• Promote an environment of Continuous Improvement and Innovation in line with Lean thinking and Process Excellence.
• Complete product validations and be capable of generating a process window.
• Implement proper housekeeping and Health & Safety standards in respect of all processes and equipment.
• Maintain equipment and processes to a very high standard of efficiency and safety.
• Maintain very high quality standards in line with supporting the quality / compliance culture by participating in root cause and corrective actions to analyze quality problems
• Ensure that procedures and work methods for areas of responsibility are accurate and fully reflect the process.
• Identify procedural deficiencies and correct

• Bachelor’s of Science in Plastics Engineering with minimum 5 years experience in plastics processing
• Must have a very good knowledge of Injection Mould tooling and design
• Experience with multi-cavity moulds and hot runner systems a plus.
• Should have a good knowledge of the principles of 5S, SMED, and Kaizen
• Technical skills in manufacturing processes and methods including flow, layout, assembly and production equipment.
• Excellent written and verbal communication skills.
• Ability to organize, prioritize and manage multiple tasks/projects.
• Strong team player, self motivated.
• Excellent problem skills with attention to detail

• Degree in Engineering, Science or equivalent is required.
• 2-3 years prior experience in a QA role required.
• Working knowledge of statistical techniques, green /black belt six sigma an advantage
• Excellent Problem Solving Skills and analytical skills and ability to handle multiple tasks in a fast paced environment.
• Capable of working as part of a multi discipline team.
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
• High level of PC skills required.

• Ensure quality of process and product as defined in appropriate OS and Material specifications.
• Ensure GMPs and system safety and promotes compliance.
• Engage and participate on the delivery of the BU KPI’s
• Continuously improve the performance of the business unit.
• Provide leadership and direction to the BU on technology development and application within the manufacturing process.
• Engage in the implementation of lean manufacture within the BU.
• Participate in FMEA and PPAP activities associated with product transfers and launches.
• Support all capital acquisition activity from specifying equipment, contract negotiation, Installation and validation
• Train manufacturing team members.
• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
• Validation, Appraisal and support of coating suppliers, machining suppliers and raw material suppliers e.g. Forgings, titanium etc.
• Support process development and cost reduction activities within the business units.
• Communicate and participate in system and process troubleshooting with support team members and with external agents.
• Lead and participate in cross-functional and cross division process improvement initiatives.

• Degree in Mechanical Engineering or equivalent is required.
• The individual must have a minimum of 2 years experience in an engineering role within a CNC environment.
• Business understanding of operations and there impacts essential.
• High level of PC Skills required.
• Flexibility essential.
• Strong communication skills with both Internal and external agents.
• Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
• Capable of working as part of a multi-disciplined team.
• Competent in preparing and implementing technology improvement strategy.

• Investigation, design, development and implementation of new manufacturing processes and technology for the introduction of new products. Liaise with Quality Assurance, Product Development, Manufacturing Engineering, Advanced Operations, Supply Chain, and others as necessary.
• Execute all administrative and regulatory requirements necessary for proper documentation and record keeping associated with new process/product introductions.
• Compilation of Capital Expenditure Requisitions for new process equipment.
• Procurement, contract negotiation, installation, validation of new manufacturing equipment, tooling and fixtures.
• Partner with strategic sourcing and supplier quality personnel for the specification and improvement of new raw materials and process consumables or the sourcing, auditing and validation of new suppliers.
• In compliance with QSR requirements, preparation and maintenance of product routings, standard operating procedures, fixtures and tooling drawings. Compilation and coordination of Engineering Bill of Materials (BOM) and Engineering Change Requests (ECR).
• Handover of new processes from development to production. Ensure all appropriate engineering prints, work instructions and other essential process related documentation is in place prior to production start.
• Will develop for new products and processes relevant:
• Manufacturing Assembly Procedures
• Equipment procurement and validation
• Fixture documentation and validation
• Process Validation and documentation
• Routings creation and maintenance
• Will provide customer service and team development with regard to achieving team goals, supporting metrics and setting and achieving training plan.

• 2-3 Years related Engineering experience in an R&D or manufacturing environment.
• Bachelor Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Electrical Engineering or Materials Science).
• Must have the ability to work with and assemble small objects and component parts
• Ability to operate small hand tools, inspection equipment, and common office equipment. Ability to operate in a fast paced environment, sometimes requiring extended work hours.
• Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
• Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, capital proposals).
• Excellent analytical skills .Excellent interpersonal communications skills
• Working knowledge of CAD/CAM/CAE computer systems.
• Working knowledge of ISO and Macro B programming.
• Working knowledge of statistical methods and process capability.
• Working knowledge of Minitab.
• Working knowledge of Electro Chemical Process