Manager, Quality Systems
Core
Lead the Quality Management System (QMS) for the Insulet Malaysia manufacturing site, ensuring regulatory compliance and driving continuous improvement across key processes.
Role type
Manager, Quality Systems
Builds
Compliant medical device manufacturing processes and quality management systems
Domain
Medical Devices / Manufacturing
Required skills
ISO 13485, CAPA management, quality auditing, change control, document control, root cause analysis (8D), regulatory compliance (FDA, EU MDR, MDSAP), KPI monitoring, team leadership
Preferred skills
MDSAP, EU MDR 2017/745, ISO 13485 Lead Auditor qualification, electronic quality management systems
Technologies
ISO 13485, MDSAP, EU MDR, FDA QMS, 8D methodology
Responsibilities
Lead QMS implementation and maintenance; oversee change order and document control; manage site quality audit program; oversee CAPA process; establish and monitor quality KPIs; ensure regulatory compliance; lead and develop the Quality Systems team
Seniority
Manager, hands-on leadership
