A fantastic opportunity for a Senior Quality Engineer to join a newly created Medical Devices company in Galway. The Senior Quality Engineer will have Electro-Chemical Devices experience and will lead quality activities to support the launch of a new medical device, including verification and validation, scaling up manufacturing, product release, and post-market monitoring. They'll ensure full compliance with the Quality Management System as production grows and matures with the contract manufacturing partner.
Overview of your responsibilities (full job description available on request):
1. Ensure compliance with FDA QSR, ISO 13485, ISO 14971, MDR and other global regulations.
2. Lead quality support for new product introduction including risk, V&V, process controls, CAPA, and documentation.
3. Develop and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation with contract manufacturers.
4. Apply risk management to meet FDA and ISO quality system requirements.
5. Drive CAPA investigations, root cause analysis, and effective corrective actions.
6. Support supplier quality through qualification, audits, and performance monitoring.
7. Participate in internal and external audits (FDA, ISO, MDSAP, NB).
8. Lead non-conformance investigations, make disposition decisions, and analyse data for trends.
9. Maintain quality metrics and support Management Reviews.
Knowledge, Skills and Experience Required for the Role:
10. Degree in Engineering, Life Sciences, or related field
11. 5–8 yrs quality engineering in medical devices
12. Electro-Mechanical Devices experience
13. Strong NPD and post-market quality experience
14. In-depth knowledge of FDA QSR, ISO 13485 & EU MDR
15. Hands-on with design controls, validation, risk, CAPA & supplier quality
16. Skilled in stats tools (. Minitab) & quality methods (FMEA, SPC, DOE, RCA)