R&D Engineering Quality Manager Public medical device company/ISO 14001:2004, ISO 13485

Quality engineering management that launched a new Class II infusion pump,led efforts to reduce cost by over $11 M/yr, managing budget of $8M in development and $3M in headcount
Responsible for managing the quality operations function and interfacing with local operations, quality and development functions to assure all products and processes are compliant and efficient.
Dispositioned non-conformance reports, research studies, engineering studies, and change control documents. Established KPIs for new product for Post Market Surveillance.