Experienced Quality Engineering professional with thirteen years of medical device industry expertise including over four years of managerial experience. Delivers strong results and works independently or in a team environment. Possesses working knowledge of ISO13485 and 21CFR Part 820.

Responsible for maintaining the Quality System in compliance with ISO13485. Served as the Management Representative. Managed Quality Engineering, Quality Control and Quality Systems. Supported design verification and validation testing. Led sterilization and packaging validation projects.

Design, Development and Manufacturing of an implant for the treatment of morbid obesity.
Provided Quality Engineering support in the development and maintenance of the Quality System. Supported design verifications and validations. Conducted sterilization validation, biocompatibility testing and process validation. Validated and maintained the Quality Management Software.

Design, Development and Manufacturing of cardiac drug eluting stents.
Provided technical Quality Engineering support for design transfer activities from R&D in Santa Rosa to Manufacturing in Ireland. Conducted design verification activities, packaging validation and stability studies.

Design, Development and Manufacturing of medical devices for hemostatic closures.
Led the Failure Analysis team and coordinated product complaint investigation with Product Surveillance (Redwood City CA, Ireland and Switzerland) and Product Development (Redwood City CA) teams. Performed detailed post market analyses of complaint tracking and trending and presented summaries at management review meetings.