Quality Engineer – Medical Device Manufacturing

About the role

We are looking for an experienced Quality Engineer to join our medical device manufacturing team in Limerick. You will provide day‑to‑day quality support to production lines while driving continuous improvement and ensuring compliance with regulatory standards.

Key responsibilities

• Provide daily quality engineering support to manufacturing lines and production operations.
• Lead and support CAPA activities, including investigations, root‑cause analysis and implementation of corrective actions.
• Manage and investigate Non‑Conformance Reports (NCRs) to ensure timely closure.
• Support validation activities such as process, equipment and test‑method validation, and review related documentation.
• Apply engineering methods (Six Sigma, Lean) to optimise manufacturing and R&D processes.
• Collaborate with Manufacturing, Engineering and Operations to resolve quality issues.
• Ensure compliance with FDA, ISO 13485, GMP and internal quality system requirements.
• Participate in internal and external audits and review quality documentation.

Required profile

• Degree in Engineering, Science, Quality or a related discipline.
• Minimum 4 years of experience in a Quality Engineering role within medical device or regulated manufacturing.
• Strong knowledge of FDA, ISO 13485 and GMP regulations.
• Proven problem‑solving and root‑cause analysis abilities.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.

Required skills

• Risk management documentation
• PFMEA
• Test‑method validation and TMV
• Product release testing
• Regulatory documentation
• CAPA management
• NCR investigation
• Process and equipment validation
• Statistical analysis
• MS Office
• CAD (advantageous)
• Six Sigma
• Lean methodologies