Quality Engineer – Product/Medical Device

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Job Description

Cpl in partnership with our client Pfizer, a leading Pharmaceutical company is hiring a Quality Engineer with in-depth external experience within the device industry. The successful candidate will be responsible for providing key technical expertise and support to Quality, Manufacturing Operations, Technical Operations/Services and Engineering for Medical Device/Combination Product manufacturing/production lines.
Contact Miki for the full information on email miki.soma@cpl.ie

Principal Duties and Responsibilities
  • Provide coaching at the site for the management of medical device/combination product in compliance with 21 CFR Part 4 requirements.
  • Provide coaching to site technical experts on the problem-solving process and reviews technical content.
  • Support and provide guidance of Corrective Action and Preventive Action (CAPA) governance processes in compliance with US FDA regulatory requirements and other applicable device regulations. Provide support on the management and administration of the Device CAPA Review Board (CRB).
  • Develops and assists in the execution of corrective/preventative action plans as needed.
  • Interfaces with individual CAPA Record owners to coach and facilitate progression through CAPA process.
  • Supports the Site Device CAPA co-ordinator as needed.
  • Ensures Manufacturing and Quality systems are compliant with applicable device quality requirements.
  • Assists with risk analysis of identified product, process and quality system issues and ensures that proper containment actions are initiated and tracked to completion.
  • Verifies that all procedural requirements are met.
  • Evaluation of device production and process methods and equipment to meet performance and quality requirements.
  • Supports manufacturing issue investigations and assigned CAPAs. Reviews and approves all manufacturing process changes and supports team reviews of change impact to the device design.
  • Monitors and analyses key performance indicators on production line such as rejects and nonconforming products.
  • Supports regular review and update of device risk management files incorporating post-production information e.g. PFMEA.
  • Attends and supports above-site design review meetings. Supports risk/impact assessments for proposed design and production process changes.
  • Participates in cross-functional teams in the preparation of risk management documentation, including product impact assessments, risk analysis, hazard analysis, Post Market Surveillance Reports, etc.
Education/Experience Requirements
  • S. in Engineering or other technical degree.
  • 5-7 years of quality engineering experience within the medical device/combination product industry with experience of regulations associated with combination products, preferably including experience of 21 CFR Part 4 and EU MDR.
  • Experience leading and project managing technical quality engineering projects for medical devices and combination products.
  • Experience facilitating and coordinating compliance to medical device/combination product regulations.
  • Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements.
  • Experience working within a mature quality management system and device QMS architecture expertise.
  • Excellent communication and interpersonal skills.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Sound decision making abilities and be able to assess the wider impact of decisions.
  • 12 Months Contract Initially
  • Location: Pfizer Grange Castle
For further information on this opportunity, please contact Miki Soma on miki.soma@cpl.ie .
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Miki Soma

Principal Consultant +353 1 634 2776 miki.soma@cpl.ie
  • Salary:Negotiable
  • Location:West Dublin
  • Type:Contract
  • Category:Engineering
  • Ref.no:JO-2005-449623_2