Quality Engineer (Medical Devices)

We are seeking a detail-oriented Quality Engineer with experience in the medical device or healthcare products industry to ensure compliance with regulatory standards and drive continuous improvement in product quality and manufacturing processes. The ideal candidate will have strong knowledge of quality systems, risk management, and regulatory requirements such as ISO 13485, FDA QSR (21 CFR Part 820), and GMP.

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.
• Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.
• Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).
• Review and approve design documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).
• Partici...