Shilpi Sinha
Head of Quality & Regulatory Affairs at Argen Corporation- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
San Diego, California, United States, US
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Credentials
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RAC-US
Regulatory Affairs Certification ProgramDec, 2008- Nov, 2024 -
CMDA
ASQ - World Headquarters -
Certified Medical Device Auditor
ASQ - World Headquarters
Experience
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Argen Corporation
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Head of Quality & Regulatory Affairs
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May 2023 - Present
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Werfen North America
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Director Quality Assurance
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May 2013 - May 2023
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Quality Assurance Director
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May 2013 - May 2023
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Quality & Regulatory Affairs Manager
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Oct 2012 - Apr 2013
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Quality Systems Manager
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Jan 2007 - Oct 2012
Responsible for: Validation System CAPA system Audits(Internal/External/Supplier) Risk Management System Responsible for: Validation System CAPA system Audits(Internal/External/Supplier) Risk Management System
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QA and Regulatory Affairs Manager
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2005 - 2007
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Quality Process Compliance Manager
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2002 - 2005
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Quality Officer
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1997 - 2001
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Education
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University of Mumbai
Masters, Microbiology -
ASQ - CMDA
Certified Medical Device Auditor also known as Certified Biomedical Auditor -
Regulatory Affairs Professional Society (RAPS)
Regulatory Affairs Certification
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