This is a 12 month contract.
The Sustaining Product Quality Engineer is responsible to provide quality oversight of device and combination products (clinical and commercial) from design transfer thru product lifecycle management. The sustaining product quality engineer will be a quality liaison between Technical Sustaining teams, Dublin Manufacturing Operations, Quality Control, Operations Quality and Quality Systems to ensure regulatory compliance with design changes, supplier changes, complaint management, risk management and quality governance. This position will be a hybrid model of working with a mix of being on site and working from home.
• Responsible for compliance and ensuring combination product lifecycle management activities align with regulations and regulatory inspections such as Notified Body and Health Authority Inspections.
• Responsible for quality oversight, participation and guidance for the review and approval of design changes.
• Partner with cross functional teams in the evaluation of supplier requests for device and combination products e.g. design changes, supplier quality governance and quality agreements.
• Responsible for documenting supplier quality agreements and periodic review of supplier quality requirements.
• Responsible for quality oversight on complaint management including evaluation of product impact relating to risk.
• Support risk management activities in maintaining up to date product risk management files.
• Support quality governance activity such as Management Review trending & reporting, ensure timely entry, processing, and closure of quality records and change controls in compliance with procedures.
• Ability to support continuous improvement initiatives and work cross functionally to develop a more robust QMS.
• Ability to work cross functionally with Tech Ops, Complaints, Quality Systems (CQSC), Supplier Quality Management, Operations.
• Communicate effectively, both verbally and in writing, internally across departments and with external partners.
• Minimum of a B.Sc. or B. Eng. degree in biomedical/mechanical engineering, Medical Device Quality, Quality Assurance or other related subject.
• Minimum of 7+ years’ experience in Quality with medical device or combination products in a regulated environment.
• Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and EU MDR Regulation (2017/745).
• Risk Management Standard for Medical Devices ISO 14971 2019
• Regulatory Audit back room experience would be desirable.
• Familiarity with SAP and Trackwise would be desirable.
• Excellent communication & presentation skills.
• An ability to work independently, as well as a member of a team in a dynamic, fast – paced environment.
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