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 multiple countries in the Asia‑Pacific region.

Key responsibilities

• Coach, develop and mentor a diverse Quality team, fostering cross‑border collaboration.
• Maintain expertise in QSRs, ISO 13485, ISO 14971, MDSAP and IVDR, ensuring compliance becomes second nature.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial teams to harmonise quality processes.
• Lead Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Act as primary contact for regulatory authorities, notified bodies and auditors throughout APAC.
• Identify and mitigate quality risks, staying ahead of regulatory changes.
• Provide annual training on audit readiness and embed a customer‑centric mindset.

Required profile

• Proven track record building quality functions across multiple APAC countries.
• Experience with both IVD and medical devices, including new product launches.
• Bachelor’s degree in engineering or related field; Master’s (MBA, Quality Management, Engineering) preferred.
• Demonstrated success managing large, culturally diverse teams.
• Strong analytical, strategic thinking and decision‑making abilities.

Required skills

• QSRs, ISO 13485, ISO 14971, MDSAP, IVDR
• Lean and Six Sigma methodologies
• Post‑market surveillance systems
• CAPA management
• Risk management and mitigation
• Audit readiness and regulatory interface