Director, Quality Assurance APAC

About the role

The Director, Quality Assurance APAC will lead the regional quality organization, ensuring compliance with regulatory standards and internal policies across Dubai and Singapore. You will shape quality strategy, harmonise processes, and drive continuous improvement for medical devices and IVD products.

Key responsibilities

• Coach, develop and mentor a multi‑country Quality team, fostering high performance and cross‑border collaboration.
• Maintain expertise in QSRs, ISO 13485, ISO 14971, MDSAP and IVDR, embedding compliance into daily operations.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial teams to align quality objectives.
• Lead Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Act as primary liaison with regulatory authorities, notified bodies and auditors throughout APAC.
• Identify and mitigate quality risks, staying ahead of regulatory changes.
• Design and deliver annual audit‑readiness training.

Required profile

• Proven track record building new Quality functions across multiple APAC countries.
• Experience in large, complex organisations handling both IVD and medical devices.
• Bachelor’s degree in engineering or related field; Master’s (MBA, Quality Management, Engineering) preferred.
• Demonstrated leadership of diverse, multi‑country teams.
• Strong analytical, strategic thinking and decision‑making abilities.

Required skills

• ISO 13485
• ISO 14971
• MDSAP
• IVDR
• Lean methodology
• Six Sigma
• Post‑market surveillance
• Risk management
• CAPA management