Industry:
Medical Devices
Work:
Cqr
Project Manager
Cambridge Endoscopic Devices 2006 - 2012
Director of Qa and Ra
Bd 1998 - 2006
Quality Assurance and Regulatory Compliance
Galileo 1996 - 1998
Facilitator-Medical Devices
Cr Bard 1989 - 1994
Operations Manager
Education:
Massachusetts College of Pharmacy and Health Sciences 2001 - 2004
Master of Science, Masters
University of Massachusetts Amherst 1972 - 1976
Bachelors, Bachelor of Business Administration, Management
Skills:
Iso 13485
Medical Devices
Design Control
Validation
Quality System
Fda
Capa
V&V
Quality Assurance
Quality Auditing
Iso 14971
Internal Audit
Management Review
Change Management
International Regulations
Gmp
21 Cfr Part 11
Quality Control
Change Control
Iso
R&D
Product Development
Sop
Root Cause Analysis
Supplier Quality
Regulatory Affairs
Ce Marking
