Senior Design Quality Engineer is required for full support of product life cycle design quality from product design to market release by world leading health technology client in Waterford.
The successful professional will provide full medical device product life cycle design quality support from product inception through sunsetting.
This includes ensuring that product development projects are executed in compliance with the design control requirements of our client’s quality management system, ISO, FDA and other regulatory agencies. Additionally, this role has oversight of the development and maintenance of medical devices history & risk management files for all assigned products.
This role also has responsibility to ensure that corporate quality management systems are implemented and effectively operating in the R&D laboratory facilities.
- Bachelor’s or Master’s Degree in Engineering, Science or similar.
- At least 5 years’ experience in Medical Device or pharmaceutical industry in Quality, R&D, Engineering roles.
- At least 5 years’ experience in Medical Device product development.
- Experience in Advanced Product Quality Planning (APQP)
- Knowledgeable of relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971)
- Familar with Risk Management and Complaint Management.
- Process Validation.
- Knowledge of structured problem solving, Six sigma, and Lean Manufacturing tools.
- Great decision making skills and good communicator.
- Ability to influence strategic decisions.
- Self-Motivated with ability to handle multiple priorities.
- Drive and apply Advanced Quality Planning principles for new product/manufacturing process development activities to ensure effective, efficient and complaint transfer to manufacturing operations.
- Certify all projects are compliant with B&L, FDA, other regulatory agency, and ISO design control requirements.
- Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements in accordance with the corporate product development process (PDP).
- Manage the documentation of product design control activities (i.e., DHF, DHFI, etc.)
- Manage product risk management requirements per ISO 14971.
- Review and approve R&D equipment qualification protocols, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, etc.
- Issue QA Product Release authorizations for new products.
- Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR), revisions to Design Risk Analysis, and input to Clinical Evaluation Reports.
- Support post launch design changes as required.
Our client offers a competitive salary and benefits package and the opportunity to work on cutting-edge medical device technology at a leading company in the industry and opportunity for international travel.
Please send your CV in confidence to email@example.com.