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Senior Quality Engineer

  • Division: Engineering
  • Contact Email: courtney.russell@collinsmcnicholas.ie
  • Job Ref: 24923

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