Quality Engineer – Medical Device Manufacturing

About the role

The Quality Engineer will support Sanmina Fermoy’s FDA‑registered, ISO‑13485 certified facility, ensuring that medical‑device printed circuit board assemblies meet the highest quality standards. The role focuses on customer satisfaction, regulatory compliance, and continuous improvement across the product lifecycle.

Key responsibilities

• Manage closed‑loop customer complaints and drive improvement initiatives.
• Generate, review, and maintain quality metrics, DMR/DHR records, and technical files.
• Collect, analyze, and report data, performing Pareto and trend analyses.
• Lead continuous‑improvement programs, including CAPA, NCM and RMA analysis.
• Support New Product Introduction through first‑article inspections and approval.
• 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‑and‑safety legislation.

Required profile

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

Required skills

• Proficiency with Microsoft Word, PowerPoint and Excel.