Director, Quality Assurance APAC

About the role

We are seeking a Director of Quality Assurance for the APAC region, based in Dubai or Singapore. The role leads the regional quality organisation, ensuring compliance with regulatory requirements and internal standards across multiple countries.

Key responsibilities

• Lead, coach and develop a diverse Quality team, fostering cross‑border collaboration.
• Maintain and advance compliance with QSRs, ISO 13485, ISO 14971, MDSAP and IVDR.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial functions to harmonise quality processes.
• Drive Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Act as primary interface with regulatory authorities, notified bodies and auditors throughout APAC.
• Assess organisational structure, address skill gaps and build a world‑class quality function.
• Identify and mitigate quality risks, staying ahead of regulatory changes.
• Provide annual training on audit readiness and quality best practices.

Required profile

• Proven experience building quality functions across multiple APAC countries and bringing IVD/medical device products to market.
• Experience in large, complex organisations with cross‑cultural teams.
• Bachelor’s degree in engineering or related field; Master’s preferred.
• Strong analytical, strategic thinking and communication skills.

Required skills

• ISO 13485
• ISO 14971
• MDSAP
• IVDR
• Lean
• Six Sigma
• Post Market Surveillance
• CAPA management