Quality Engineer – Medical Device Manufacturing

About the role

Sanmina’s Fermoy facility in Ireland is seeking a Quality Engineer to support the production of high‑quality PCBAs and medical devices. The role focuses on ensuring customer satisfaction by monitoring, controlling and continuously improving quality processes in a regulated environment.

Key responsibilities

• Manage closed‑loop customer complaints and drive improvement initiatives.
• Generate, review and maintain quality metrics and reporting systems.
• Maintain DMR/DHR records and technical files.
• Collect, analyse and report data, including Pareto and trend analysis.
• Lead continuous improvement programs and NPI approvals, including first‑article inspections.
• Perform CAPA, NCM and RMA analysis and implement corrective actions.
• Develop and execute validation protocols (IQ, OQ, PQ) and conduct internal audits.
• Ensure compliance with FDA QSR, ISO 9001, ISO 13485, ISO 14001 and health & safety regulations.

Required profile

• Minimum NFQ Level 7 degree or diploma in Science or Engineering, or equivalent experience.
• 2–3 years of quality assurance or regulatory affairs experience, preferably in electronics manufacturing.
• Ability to respond to internal and regulatory inquiries and to author SOPs and training documents.

Required skills

• Proficiency with Microsoft Word, PowerPoint and Excel.
• Experience with quality metrics systems, DMR/DHR management, CAPA, NCM and RMA analysis.
• Knowledge of first‑article inspection, IQ/OQ/PQ validation and audit procedures.