Amgen
Director, Ivd and Device Regulatory Affairs
Amgen Mar 2013 - Aug 2018
Senior Manager, Device Regulatory Affairs
Shl Medical Feb 2010 - Jan 2013
Director, Quality Systems and Regulatory Affairs
Shl Medical Mar 2009 - Feb 2010
Manager, Quality System Audits
The Yeh Group Mar 2006 - Mar 2009
Owner and Consultant
Education:
University of Michigan
University of Michigan
Bachelor of Science In Engineering, Bachelors, Materials Science, Engineering
Skills:
Quality System Medical Devices Fda Iso 13485 Regulatory Affairs Capa Validation Iso 14971 Biotechnology Design Control Gmp R&D V&V Product Development Fmea Manufacturing