An excellent opportunity for a Senior Quality Engineer to join a MedTech company in Galway. We’re looking for a detail-focused Senior Quality Engineer to join the Operations team. This key role will ensure top quality and compliance across manufacturing, helping deliver life-changing medical devices.
Overview of your responsibilities (full job description available on request):
- Knowledge, Skills and Experience Required for the Role:
- Support and mentor Quality Engineers and Technicians, assigning tasks and giving clear feedback.
- Drive continuous improvement through CAPA and KPI analysis.
- Lead quality projects and ensure milestones are met on time.
- Maintain GMP standards and compliance in your area.
- Collaborate with Operations, Supply Chain, and other teams to ensure product and process quality.
- Lead or participate in Risk Analysis (e.g. FMEA).
- Review and approve validation protocols, reports (IQ/OQ/PQ), and engineering changes.
- Maintain documentation in line with FDA and ISO requirements.
Knowledge, Skills and Experience Required for the Role:
- Degree in Engineering, Life Sciences, or related field
- Level 8 Degree in Science, Engineering, Quality or similar.
- 5+ years’ experience in the medical device industry.
- Strong knowledge of quality systems, measurement techniques, FDA & ISO standards (ISO 13485, 21 CFR Part 820).
- Proven CAPA and root cause problem-solving experience.
- Solid background in test method and process validation.
- Highly organised with the ability to work independently.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062