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 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