Science
Principal Quality Engineer
- TypePermanent
- SalaryNegotiable
- LocationDublin
- Published13 Dec 2023
- Ref#BBBH13887
- Apply now!
Principal Quality Engineer
About the Client: Azon is delighted to be partnered with a global Medical Device organisation in Dublin for the recruitment of a Principal Level Quality Engineering in NPI and Design control activities.
Location: Dublin – Hybrid
About the Role:
- Transfer of project and quality/business strategies into Quality Plans to include risk management, process validation & control strategies from raw material to commercial product
- Ensure design control activities are satisfied in effective and efficient manner
- Lead product related risk management activities
- Ensure quality conduct of project, including design, data summary, interpretation and report generation.
- Assist/conduct complex failure investigations and problem-solving sessions for non-conforming products.
- Review Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.
About the Person:
- BSc minimum in Engineering or Scientific discipline
- 7+ years’ relevant experience, in a ISO13485/GMP Medical Device environment
- Detailed understanding of industry regulations/standards: ISO 13485, QSR, GMP, ISO 14971, ISO 62304, IEC 60601
- Extensive knowledge and expertise of design control principles, risk analysis and change control
- Exhibit knowledge and experience of statistical techniques of growing complexity, quantitative and qualitative, to facilitate design and process analysis, including improvements (Reliability Engineering, DMAIC, or Lean)
Amara McCalliog
Principal Recruitment Consultant - Life Sciences
Amara, based in our Dublin office is the Principal Recruitment Consultant for Life Sciences and specialises in QC, R&D and technical based roles. Amara obtained a BSc. in Biology and Applied Mathematics at Maynooth University. Following her studies, Amara gained invaluable laboratory experience through her roles as a Laboratory Technician and Deputy Team Lead of a Molecular Biology Department. From here, Amara moved into recruitment of laboratory based roles and can offer permanent, contract and temporary recruitment solutions.