Director, Quality Assurance APAC

Are you passionate about elevating quality standards and making a real impact in healthcare? Do you thrive on leading diverse teams and driving strategic initiatives across international markets?

Requirements

• Lead & Inspire: Coach, develop and mentor our talented Quality team, fostering growth, high performance, and cross-border collaboration.
• Quality Champion: Advance knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR and all relevant regulations—making compliance second nature.
• Strategic Partner: Collaborate with Regulatory, Operations, R&D, Supply Chain, Legal, and Commercial teams to drive quality objectives and harmonize processes.
• Continuous Improvement: Lead Lean, Six Sigma, and data-driven initiatives to manage non-conformances, CAPAs, complaints, and post-market surveillance.
• Voice of the Customer: Embed a customer-centric mindset across the organization, ensuring customer needs are the foundation of every quality activity.
• Regulatory Interface: Act as primary contact for regulatory authorities, notified bodies, and auditors throughout APAC.
• Talent Developer: Assess organizational structure, address skill gaps, and coach team members to build a world-class quality function.
• Risk Manager: Proactively identify and mitigate quality risks, staying ahead of regulatory changes and industry best practices.
• Training & Development: Provide annual training on audit readiness

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance