Organization-level leader of Manufacturing Quality in the medical device industry with extensive experience improving manufacturing quality and enhancing organizational efficiency. Expertise in regulatory compliance and sustaining product quality. Impactful leader with a successful track record of leading diverse teams. Dedicated to driving sustainable improvements in product quality and creating a progressive quality mindset in a dynamic regulatory environment.Seasoned in new product introductions and scale-up, production line transfers, plant start-up, external audit management, regulatory body relationship management, risk management, lifecycle management of Class II and Class III devices, supplier development and management, capacity planning, strategy development. Hands-on experience in practical implementation and sustaining of improvements using Six Sigma Quality and Lean Manufacturing principles.
Listed skills include Fda, Iso 13485, Medical Devices, Validation, and 16 others.