Excellent opportunity for a Senior Quality Engineer to join a Medical Devices company in Galway. The Senior Quality Engineer supports and enhances all site quality activities across operations, design assurance, and quality systems - providing expert quality input throughout the full product lifecycle, from design to post-market stages.
Overview of your responsibilities (full job description available on request)
Lead and support the Quality Engineering and Technician team to meet goals.
Provide quality leadership across manufacturing and NPI projects.
Maintain and improve the QMS, including audits, CAPA, and document control.
Manage product and process risk in line with ISO 14971.
Oversee supplier qualification, audits, and non-conformance management.
Approve batch release, product disposition, and key quality decisions.
Knowledge, Skills and Experience Required for the Role:
Degree in Engineering, Science, or related field.
5+ years? experience in the 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 ability to work effectively across teams in a regulated, fast-paced environment.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
