Director, Quality Assurance APAC

About the role

The Director, Quality Assurance APAC will lead the regional quality organization from either Dubai or Singapore. You will be responsible for ensuring high quality standards, regulatory compliance and continuous improvement across the APAC market.

Key responsibilities

• Lead, coach and mentor the APAC Quality team, fostering high performance and cross‑border collaboration.
• Champion compliance with QSRs, ISO 13485, ISO 14971, MDSAP, IVDR and other relevant regulations.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial teams to align quality objectives.
• Drive Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Embed a customer‑centric mindset throughout quality activities.
• Act as primary contact for regulatory authorities, notified bodies and auditors across APAC.
• Assess organizational structure, address skill gaps and develop a world‑class quality function.
• Identify and mitigate quality risks proactively, staying ahead of regulatory changes.
• Provide annual training on audit readiness and quality best practices.

Required profile

• Proven track record building new Quality functions across multiple APAC countries.
• Experience in large, complex organisations handling both IVD and medical devices.
• Successful history of bringing new products to market.
• Expertise in large‑scale QMS harmonisation projects.
• Experience creating robust post‑market surveillance systems.
• Bachelor’s degree in engineering or related field (Master’s preferred).
• Demonstrated leadership of diverse, multi‑country teams.
• Strong analytical, strategic thinking and decision‑making abilities.
• Excellent communication and influencing skills at all organisational levels.

Required skills

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