Highly focused and results-driven Operations Leader and Quality Executive with 24 years Medical Device experience in the following areas: international team development and management of product life-cycle from design and development, design transfer, supplier qualification and monitoring, manufacturing production and process controls, acceptance activities, and post-market surveillance to continuous improvement. Experienced in the manufacture of consumable and capital equipment medical devices of all classifications (I, II, & III) for global market distribution under scrutiny of multiple regulatory and standards agencies. A strong strategic thinker and driver, effective with stakeholder engagement in both line and matrix organizations working across borders, nationalities, cultures and time zones.