Pelvalon 2015 - Jul 2016
Qa Consultant
Zipline Medical 2015 - Jul 2016
Director Quality Assurance and Regulatory Affairs
Earlens Corporation 2015 - 2015
Director, Quality
Arqos Surgical, Inc. 2012 - Nov 2014
Vice President Qa
Minerva Surgical, Inc. Mar 2011 - Dec 2011
Qa Consultant
Education:
Santa Clara University 1988 - 1993
Master of Business Administration, Masters, Business
University of California, Berkeley 1981 - 1985
Bachelors, Bachelor of Arts, Applied Mathematics
Skills:
Quality System Quality Assurance Iso 13485 Fda Medical Devices Design Control Capa Quality Control Validation Gmp V&V Iso 14971 Manufacturing Fmea Quality Management Change Control 21 Cfr Part 11 Quality Auditing Supplier Quality R&D Sop Dmaic Iso 21 Cfr U.s. Food and Drug Administration Regulatory Affairs Lean Manufacturing Root Cause Analysis Design of Experiments Cqa Gxp Computer System Validation Spc