Excellent opportunity for a QA Manager with proven people management experience to join a Medical Devices company in Galway. The QA Manager will lead a Quality team supporting both manufacturing and new product development. This role will ensure compliance with ISO 13485, 21 CFR 820, and EU MDR while driving continuous improvement. Ideal for an experienced Quality Manager or Senior Quality Engineer ready to step into leadership.
Overview of your responsibilities (full job description available on request)
Lead, develop, and support the Quality Engineering and Technician team to achieve departmental and company
objectives.
Provide Quality leadership and technical input across manufacturing and new product introduction projects
Ensure effective operation and continual improvement of the QMS, including document control, calibration,
internal audits, and CAPA/NCR processes
Oversee product and process risk management in compliance with ISO 14971.
Manage supplier approval, qualification, and audits, and address supplier‐related non‐conformances.
Oversee batch release, product disposition, and related quality decisions.
Provide guidance to teams in developing and approving protocols, reports, and change control documentation.
Knowledge, Skills and Experience Required for the Role:
Degree in Engineering, Science, or related technical field.
5+ years’ experience in Medical Device or Pharma industry.
2+ years in a senior or supervisory Quality role.
Strong knowledge of QMS and regulations (ISO 13485, 21 CFR 820, MDR).
Proven cross-functional collaboration in regulated, fast-paced settings.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
