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Sean Yohey Location
Sacramento, CA, US
Sean Yohey Work
Sr Director of Quality Systems @ (May 2022 - Present)
Consultant to the Medical Device and Bio-pharmaceutical industry @ SynerGxp, llc (May 2021 - Present)
Consultant to the Medical device and Bio-Pharmaceutical Industry @ Open (September 2017 - Present)
Compliance Sr. Manager @ (April 2018 - May 2021)
Quality Systems Consultant @ (November 2016 - July 2017)
Quality Systems and Change Management Consultant @ (June 2016 - September 2016)
Quality Systems and Risk Management Consultant @ (June 2015 - June 2016)
Sr Manager Quality Systems @ (July 2011 - January 2015)
Consultant @ SynerGxP, LLC (October 2008 - July 2011)
Quality Assurance and Compliance @ (June 2005 - May 2008)
Quality Assurance and Compliance Manager @ (April 2004 - February 2005)
GM @ Baxter Heatlhcare (October 2003 - May 2004)
GM @ Alpha Therapeutic (May 2002 - April 2004)
Sean Yohey Education
University of California, Davis
B.S (Biotechnology)
Sean Yohey Skills
Leadership
Auditing
Quality Management
Design Control
Clinical Trials
Customer Relations
510 K
ISO 14971
SDLC
Root Cause Analysis
cGMP
GMP
ISO
21 CFR Part 11
Start Ups
GxP
Troubleshooting
Biotechnology
Regulatory Affairs
Change Control
Life Sciences
Validation
Process Improvement
IEC 62304
Quality Assurance
Medical Devices
Strategic Planning
Compliance
Regulatory Requirements
Quality System
Clinical
Risk Management
Leadership Development
Cross Functional Team Leadership
Change Management
Mdd
Regulatory Submissions
CLIA
Management
Quality Control
Cmdcas
Pharmaceutical Industry
LIMS
CAPA
Quality Systems
FDA
Sop
IVD
CQA
ISO 13485
Sean Yohey Summary
Sean Yohey, based in Sacramento, CA, US, is currently a Sr Director of Quality Systems at MEDIcept Inc.. Sean Yohey brings experience from previous roles at SynerGxp, llc, Open, Philips and Medtronic. Sean Yohey holds a B.S in Biotechnology @ University of California, Davis. With a robust skill set that includes Leadership, Auditing, Quality Management, Design Control, Clinical Trials and more. Sean Yohey has 1 emails and 1 mobile phone numbers on RocketReach.
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