Director, regulatory affairs, compliance and quality, japan
Education
School / High School:
University of Utah
2000 to 2006
Specialities:
Business
Skills
Medical Devices • Fda Gmp • Iso 13485 • Iso 14971 • Strategic Business and Regulatory Affair... • Design Control • Japanese Business Culture • Japanese Pal • Process and Product Risk Management • Root Cause Analysis • Process Improvement • Sterility Assurance • Clean Rooms • Water Purification • Cleaning Validation • Validation • Manufacturing and Quality Engineering • Iq/Oq/Pq of Equipment/Processes/Systems • Clean Rooms and Purified Water Systems • Packaging and Sterilization of Medical D... • Quality System Software Validations • Project Management • Leadership and Teambuilding • Planning and Implementing Programs • Technical Writing • Risk Management • Machining • Regulatory Submissions • Microsoft Excel • Fda • Microsoft Word • Capa • Customer Service • Microsoft Office • Quality Assurance • Cross Functional Team Leadership • Powerpoint • Quality System • Regulatory Affairs • Iso • V&V • Manufacturing • Product Development • U.s. Food and Drug Administration
Languages
Japanese • Korean • Spanish
Industries
Medical Devices
Resumes
Principal Consultant, Currently Holding The Position Of Vice President Of Quality
Kinetic Concepts - San Antonio, TX and Tokyo, Japan since Apr 2011
Director, Regulatory Affairs, Compliance and Quality, Japan
Kinetic Concepts - San Antonio, TX; Tokyo Japan Aug 2009 - Apr 2011
Director of Regulatory Affairs
Orthofix - McKinney, TX Oct 2006 - Aug 2009
Director of Quality Assurance and Regulatory Affairs
ZEVEX/Moog Inc. - Salt Lake City, UT Sep 2005 - Oct 2006
Quality Manager
Ortho Development - Draper, UT; Tokyo, Japan Aug 2000 - Aug 2005
Director of Quality Assurance / Regulatory Affairs
Education:
University of Utah 2000 - 2006
Utah State University 1997 - 2000
The University of Texas at San Antonio
BS International Business, 3.978 GPA., International Business
Skills:
Medical Devices Fda Gmp Iso 13485 Iso 14971 Strategic Business and Regulatory Affairs Planning Design Control Japanese Business Culture Japanese Pal Process and Product Risk Management Root Cause Analysis Process Improvement Sterility Assurance Clean Rooms Water Purification Cleaning Validation Validation Manufacturing and Quality Engineering Iq/Oq/Pq of Equipment/Processes/Systems Clean Rooms and Purified Water Systems Packaging and Sterilization of Medical Devices Quality System Software Validations Project Management Leadership and Teambuilding Planning and Implementing Programs Technical Writing Risk Management Machining Regulatory Submissions Microsoft Excel Fda Microsoft Word Capa Customer Service Microsoft Office Quality Assurance Cross Functional Team Leadership Powerpoint Quality System Regulatory Affairs Iso V&V Manufacturing Product Development U.s. Food and Drug Administration
Languages:
Japanese Korean Spanish
Youtube
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