Clarkston Consulting
Manager and Medical Device Industry Community Lead
Siemens Healthcare Oct 2010 - Sep 2013
Director, Quality - Customer Solutions Usa
Siemens Healthcare Jan 2009 - Oct 2010
Senior Manager, Raqs-Ehs
Animas Corporation May 2006 - Dec 2008
Quality Manager
Baxter International Inc. Sep 2004 - May 2006
Quality Associate Iii
Education:
Golden Gate University 1989
Master of Business Administration, Masters, Management
Clemson University 1980 - 1984
Bachelors, Bachelor of Science, Food Science
Skills:
Capa Quality Assurance Iso 13485 Quality System Fda Medical Devices Validation Design Control V&V Quality Auditing Iso 14971 Quality Management Quality Control Root Cause Analysis Fmea Gmp Iso Change Control 21 Cfr Part 11 Design of Experiments Minitab Orthopedic Regulatory Affairs Dmaic Fda Gmp Spc R&D Sop Corrective and Preventive Action Iso Standards Iso 9000 Lifesciences U.s. Food and Drug Administration Supplier Quality Document Management