Quality Engineer – Medical Device Manufacturing

About the role

We are seeking a proactive Quality Engineer to join a leading medical device manufacturer in Shannon. The successful candidate will support both new and existing product lines, ensuring compliance with ISO 9001 and AS9100 standards while driving continuous improvement.

Key responsibilities

• Maintain and update QMS documentation, records, and systems.
• Conduct internal audits, report findings, and close non‑conformances.
• Lead CAPA activities and root‑cause investigations using proven quality tools.
• Support NPI projects, including product and process verification.
• Analyse processes and implement improvements to boost capability and performance.
• Assist engineering teams with calibration management and verification activities.
• Coordinate quality‑related projects and provide support to operations.

Required profile

• 2‑3 years of experience in a quality role within a regulated manufacturing environment.
• Strong self‑direction, motivation and ability to prioritize competing tasks.
• Excellent interpersonal, written and verbal communication skills.
• Proven auditing experience in a manufacturing setting.
• Detail‑oriented with solid investigative and problem‑solving abilities.

Required skills

• ISO 9001 and/or AS9100 quality management systems.
• MS Office proficiency.
• Experience with NPI (New Product Introduction) activities.
• CAPA (Corrective and Preventive Action) processes.
• Knowledge of APQP and PPAP documentation.
• Calibration system operation.
• Understanding of sheet‑metal and machining processes.