Quality Engineer – Manufacturing & Regulatory Compliance

About the role

The Quality Engineer ensures product quality, regulatory compliance, and customer satisfaction within a manufacturing environment. Acting as the primary interface with customers, the role manages complaints, returns, and drives continuous improvement initiatives.

Key responsibilities

• Oversee quality systems and documentation, including DMR/DHR and technical files.
• Monitor quality metrics, process performance, and conduct data analysis for improvement.
• Support New Product Introduction (NPI) through inspections, approvals, and validation activities (IQ/OQ/PQ).
• Manage CAPA, non‑conformances, and internal audits to maintain an effective QMS.
• Ensure compliance with FDA QSR, ISO 9000, ISO 13485, and health & safety regulations.

Required profile

• NFQ Level 7 qualification in Science or Engineering, or equivalent experience.
• 2–3 years of experience in Quality Assurance or Regulatory Affairs, preferably in electronics or medical device manufacturing.
• Strong problem‑solving methodology knowledge.
• Excellent communication and stakeholder‑influence skills.

Required skills

• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Experience developing SOPs, training materials, and regulatory documentation.
• Six Sigma Green Belt or Black Belt certification (desirable).