Requirement:

• Minimum 10 years of experience in Quality Management System / QA, with at least 5 years driving QMS governance, regulatory alignment, seamless audit execution, and Lean-based improvement culture across medical device operations.
• Lead the end-to-end development, implementation, and governance of the Quality Management System (QMS) across all operational units to ensure world-class quality excellence.
• Safeguard full compliance with ISO standards, regulatory requirements, internal policies, and customer expectations, driving a culture of audit-readiness and zero-defect performance.
• Analyze performance metrics and quality intelligence to unlock opportunities and accelerate improvement.
• Direct internal & external audit programs, ensuring timely closure of CAPs and flawless certification outcomes.
• Collaborate closely with Production, QA, Engineering, Maintenance, and Compliance teams to reinforce system integrity and elevate overall product quality and reliability.
• Monitor QMS KPIs and performance dashboards, delivering strategic insights and executive-level reporting to top management to accelerate decision-making and quality transformation.
• Proven ability to lead diverse teams toward quality excellence, supported by sharp analytical thinking and the ability to communicate complex information with clarity and influence.
• Good in English, both spoken and written; proficiency in Mandarin is a plus. A Bachelor’s or Master’s degree in Industrial Engineering, Pharmacy, or related field.