Quality Engineer

About the role

The Quality Engineer will support Sanmina's FDA‑registered, ISO‑13485:2016 certified facility in Fermoy, Ireland. You will act as the primary customer interface for quality metrics, ensuring compliance with regulatory standards and driving continuous improvement across the manufacturing of high‑quality PCBAs and medical devices.

Key responsibilities

• Manage closed‑loop customer complaints and improvement processes.
• Generate, review, and maintain the Quality Metrics System.
• Maintain DMR/DHR records and technical files.
• Collect, analyze, and report data, including Pareto and trend analyses.
• Lead continuous improvement programs and NPI approvals, including first‑article inspections.
• Conduct CAPA, NCM, and RMA analyses and implement improvements.
• Develop and execute QSR validation protocols (IQ, OQ, PQ) and conduct internal audits.
• Ensure ongoing compliance with FDA QSR, ISO 9001, ISO 13485, ISO 14001, and health & 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 or medical device manufacturing.
• Ability to respond to internal and regulatory inquiries and draft SOPs, training documents, and regulatory responses.

Required skills

• Proficient in Microsoft Word.
• Proficient in Microsoft PowerPoint.
• Proficient in Microsoft Excel.