Product Quality Engineer – Medical Devices

About the role

The Product Quality Engineer will support design controls and quality management for medical device development, transfer and sustaining initiatives. You will lead quality elements of design controls, risk management and post‑market surveillance in line with Philips processes and global standards.

Key responsibilities

• Lead all quality elements of Design Controls and maintain product Design History Files.
• Drive quality norms for design engineering projects and integrate risk management throughout the product lifecycle.
• Support regulatory submissions and respond to related queries.
• Lead and support CAPA and continuous QMS improvement initiatives.
• Analyze data using engineering principles to identify gaps between project work and QMS.
• Transfer quality deliverables for new and sustaining products to manufacturing, operations and supplier quality teams.
• Support internal and external audits and ensure compliance with applicable regulatory requirements.

Required profile

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 8‑10 years of experience in quality engineering, safety engineering or R&D engineering for medical devices.
• Preferred certification: Six Sigma Green Belt.

Required skills

• Design Quality Management and Design for Quality (DFQ).
• Standards: ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601‑1, IEC 62366, IEC 62304.
• Root Cause Analysis (RCA) and CAPA methodologies.
• Data analysis & interpretation, technical documentation, and continuous improvement.
• Product Lifecycle Management (PLM) and risk assessment.