Quality Engineer

We are seeking a Quality & Regulatory Engineer to play a key role in ensuring product and process compliance, managing customer quality metrics, and supporting regulatory alignment across global standards (FDA QSR, ISO 13485, JPAL, etc.).

This role is ideal for someone with a strong quality background who enjoys customer interaction, driving improvements, and working in a regulated manufacturing environment.

Key Responsibilities:

• Lead customer complaint investigations and drive corrective action (CAPA, NCM, RMA)
• Own and maintain DMR/DHR records and Technical Files
• Analyze and report on quality metrics (yield, scrap, returns, etc.)
• Perform Pareto/trend analysis to support continuous improvement
• Manage quality inputs for NPI projects, including First Article Inspections
• Support validation activities (IQ/OQ/PQ)
• Conduct internal audits and support external inspections
• Ensure ongoing compliance with quality and H&S regulations

Requirements:

• Degree (NFQ Level 7+) in Science or Engineering (or relevant experience)
• 2–3 years' experience in Quality Assurance or Regulatory Affairs, ideally in electronics manufacturing
• Skilled in root cause analysis and problem-solving techniques
• Proficient in Microsoft Office (Excel, PowerPoint, Word)
• Strong communication and documentation skills

Desirable:

• Experience in medical device manufacturing
• Six Sigma Green or Black Belt certification
• Familiarity with New Product Introduction (NPI) processes