Quality System • Quality Assurance • Quality Management • Iso 13485 • Fda • 21 Cfr Part 11 • R&D • Change Control • Medical Devices • Technology Transfer • Commercialization • Cross Functional Team Leadership • Design For Manufacturing • Product Development • Validation • Process Simulation • Biomedical Engineering • U.s. Food and Drug Administration • Research and Development
Cre8Mdi, Llc
Vice President Quality and Regulatory
Enginivity Nov 2004 - Oct 2010
Software Systems and Regulatory
Education:
Bentley University
Associates, Management
University of Massachusetts Lowell
Bachelors, Management
Skills:
Quality System Quality Assurance Quality Management Iso 13485 Fda 21 Cfr Part 11 R&D Change Control Medical Devices Technology Transfer Commercialization Cross Functional Team Leadership Design For Manufacturing Product Development Validation Process Simulation Biomedical Engineering U.s. Food and Drug Administration Research and Development