Manager, Quality Systems

The Quality System Manager leads the Quality Management System (QMS) for the Insulet Malaysia manufacturing site, overseeing governance, change review, document control, auditing, CAPA, and regulatory compliance. The role partners with local and global teams to maintain an effective QMS, drive continuous improvement, and ensure adherence to medical device regulations like ISO 13485, FDA, and EU MDR. This position requires strong leadership, analytical skills, and experience in quality systems within the medical device industry.