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
