Compliance and Quality Specialist – CAPA

About the role

The Compliance Quality Engineering Team of Philips manages quality engineering processes for commercial operations, handling non‑conforming investigations, equipment calibration issues, out‑of‑tolerance cases and other non‑conformities to support compliance, continuous improvement, patient safety and maintain the license to operate.

Key responsibilities

• Lead a group in defect analysis to determine dispositions of non‑conformances and manage those non‑conformances.
• Facilitate effective Corrective and Preventive Actions (CAPA) and support continuous improvement within the Quality Management System (QMS).
• Propose and implement enhancements to processes, tools and systems while building strong relationships with internal and external partners.
• Drive overall quality performance and operational excellence to ensure regulatory compliance through improvement initiatives.
• Support the Asia Pacific region including ANZ, Philippines, Vietnam, Thailand, Malaysia, Indonesia and other countries as needed.

Required profile

• Bachelor’s degree in a science, engineering, health & safety, medical technology, pharmacy or biomedical engineering field.
• Minimum 3 + years experience in Quality Assurance, Quality Control, Regulatory Affairs, CAPA, Supplier Quality or Risk Management.
• Experience with medical devices and/or pharmaceuticals preferred; automotive industry experience also acceptable.
• Basic understanding of CAPA, global medical device or pharmaceutical regulations and standards such as ISO 13485, ISO 9001 and ISO 14971.
• FDA experience is advantageous and strong communication, stakeholder management and flexibility are required.

Required skills

• Microsoft Excel
• Microsoft PowerPoint