The Tova Company
Regulatory and Quality Manager
Kimberly-Clark Jun 2013 - Sep 2014
Qara Technical Project Lead
Mt Tabor Regulatory & Quality Consulting Jun 2013 - Sep 2014
Principal Consultant
Biomerieux May 2009 - Jan 2010
Quality Engineer
Hemcon Medical Technologies Jun 2005 - Oct 2008
Quality Engineer
Education:
University of Southern California 1993 - 1995
Master of Science, Masters, Biomedical Engineering
University of Michigan 1989 - 1993
Bachelors, Bachelor of Science, Bioengineering, Engineering, Mechanical Engineering
Fountain Valley Hs
Skills:
Fda Iso 13485 Medical Devices Quality System Capa Design Control Regulatory Affairs Validation V&V Iso Gmp Cross Functional Team Leadership Quality Control R&D Product Development Testing Quality Assurance Biomedical Engineering Root Cause Analysis 21 Cfr Part 11 Quality Auditing Six Sigma Iso 14971 Quality Management Auditing Regulatory Submissions Design of Experiments Process Validation Regulatory Requirements 510 K Cgmp Certified Internal Auditor Quality Systems Fmea Iso 13485 Lead Auditor Certified Asq/Rab Sop Ce Marking Pma Management Review Qsr Fda Inspections Ide Inspection Quality Engineering Supplier Quality Clinical Trials Risk Management Cmdcas Cmdcas Auditor Certified
Interests:
Children Economic Empowerment Education Environment Poverty Alleviation Disaster and Humanitarian Relief Human Rights Animal Welfare Health
Languages:
Spanish
Certifications:
Iso 13485 Lead Auditor Cmdcas Lead Auditor Rab/Asq Health Canada
Jun 2013 to 2000 QA RA Technical LeadTabor Regulator & Quality Consulting, LLC
Sep 2011 to 2000 Principal ConsultantBayer Diabetes Wilsonville, OR Oct 2012 to May 2013 QA RA ConsultantSonivate Portland, OR Jul 2012 to Oct 2012 Consultant Quality SystemsSt. Jude Medical Portland, OR Oct 2011 to Mar 2012 Quality Enginering ConsultantTyco Electronics Wilsonville, OR 2010 to Jan 2011 Regulatory and Quality Project ManagerbioMrieux, Inc Portland, OR May 2009 to Jan 2010 Quality EngineerHemcon Medical Technologies, Inc Portland, OR Jun 2005 to Oct 2008 Quality EngineerBIOTRONIK, Inc Portland, OR Oct 1998 to Jun 2005 Regulatory Affairs CoordinatorAllergan, Inc Irvine, CA Jul 1997 to Sep 1997 Regulatory Affairs AnalystMedical Data Electronics Arleta, CA Feb 1995 to Jun 1997 Software Validation/Clinical Engineer
Education:
University of Southern California Los Angeles, CA 1993 to 1995 M.S. in Biomedical EngineeringUniversity of Michigan Ann Arbor, MI 1989 to 1993 B.S. in Mechanical Engineering and B.S