➢ Drive improvement activities to achieve quality metrics and goal, yield improvement at customer incoming and reduce RMA➢ Drive improvement in non-conforming material reduction from incoming and in-process and ensure timely disposition and removal from inventory➢ Leading and carrying out root cause analysis for nonconformance in areas such as final QA rejections, NCMRs (nonconforming material reports), CAPAs (corrective and preventive action), and customer complaints.➢ Supervise QA team for TMV (test method validation) and support engineering team for medical device validation activities (IQ, OQ, PQ,)➢ Lead QA team in customer audit, support supplier audit and ISO 13485, ISO 9001 audit (both on site and remote audit)➢ Coach and supervise QA engineer/technicians on operation and technical issues with the aim towards zero defect➢ Recruit, manage, develop, coach and develop SME (subject matter expert) among QA Engineers and QA technician team➢ Establish comprehensive inspection criteria for New Product Introduction (NPI) initiatives.➢ Manufacturing process control implementation: pFMEA and control plan➢ Contributes to value enhancement by assisting supply chain operations with localization initiatives, thereby enabling the utilization of alternative suppliers.➢ Interface with various departments to ensure the comprehensive completion of customer surveys, questionnaires, and audit checklists➢ Facilitate the implementation of Production Part Approval Process (PPAP)/ Advanced Product Quality Planning (APQP)➢ Interface with customer, Corporate Customer Director, Corporate QA Director, Legal Team to establish Quality Agreement with customer➢ Collaborate with the regional team to develop and execute Quality Awareness programs, such as the ‘Quality Begins with Me’ (QBwM) initiatives.➢ Engage in strategic collaboration with the Corporate Manufacturing Execution System (MES) team to drive enhancements in business processes.