Quality Engineer – Medical Device Manufacturing

About the role

We are seeking a Quality Engineer to join the Quality Department at our FDA‑registered, ISO‑13485:2016 certified facility in Fermoy, Ireland. The role focuses on ensuring customer satisfaction by monitoring, controlling and continuously improving quality processes for medical‑device PCBAs and assemblies.

Key responsibilities

• Manage closed‑loop customer complaints and drive improvement initiatives.
• Generate, review and maintain the Quality Metrics System.
• Maintain Device Master Records (DMR), Device History Records (DHR) and technical files.
• Collect, analyse and report data, including Pareto and trend analysis.
• Lead continuous improvement programs and support New Product Introduction (NPI) approvals, including first‑article inspections.
• Conduct CAPA, NCM and RMA analysis and implement corrective actions.
• Develop and execute QSR validation protocols (IQ, OQ, PQ) and audit the quality system for compliance.
• Ensure adherence to health & safety legislation and monitor key process yields, scrap rates, and inspection metrics.

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, preferably in electronics manufacturing.
• Proven ability to respond to internal and external inquiries, write SOPs, training documents and regulatory responses.

Required skills

• Microsoft Word, PowerPoint and Excel.
• Knowledge of FDA Quality System Regulations (QSR), ISO 9001, ISO 13485 and ISO 14001.
• Experience with CAPA, NCM and RMA processes.
• Audit execution and reporting.
• Validation protocol development (IQ, OQ, PQ) and first‑article inspection.