2007 -2012 Quality Systems Manager @ Focus Diagnostics,Quest Diagnostics
2005 -2007 QA and Regulatory Affairs Manager @ Peptisyntha Inc.( A Solvay America Company)
2002 -2005 Quality Process Compliance Manager @ Solvay Draka ( A Solvay America Company)
1997 -2001 Quality Officer @ Aventis
Shilpi Sinha Education
University of Mumbai
ASQ - CMDA
Certified Medical Device Auditor also known as Certified Biomedical Auditor
Regulatory Affairs Professional Society (RAPS)
Regulatory Affairs Certification
Shilpi Sinha Skills
Design Control
Talent Management
Strategy Alignment
Corrective and Preventive Action (CAPA)
Internal Audits
Supplier Audits
Regulatory Audits
Cross-functional Team Leadership
Change Management
Product Development
Document control
QA Engineering
Supplier Quality Management
IVDR
MDSAP
U.S. Title 21 CFR Part 11 Regulation
NMPA
ANVISA
CAPA
Quality System
ISO 13485
FDA
ISO 14971
21 CFR
Quality Auditing
FDA GMP
Technology Transfer
21 CFR Part 11
Design of Experiments
GMP
Medical Devices
Regulatory Affairs
V&V
Validation
Quality Assurance
Research
Integration
Engineering
Pharmaceutical Industry
Microsoft Office
Strategic Planning
Troubleshooting
Project Management
Public Speaking
Shilpi Sinha Summary
Shilpi Sinha, based in Seattle, WA, US, is currently a Head of Quality Assurance and Regulatory Affairs at Magnolia Medical Technologies. Shilpi Sinha brings experience from previous roles at Argen Corporation, Inova Diagnostics and HemoCue Inc, Quest Diagnostics. Shilpi Sinha holds a University of Mumbai. With a robust skill set that includes Design Control, Talent Management, Strategy Alignment, Corrective and Preventive Action (CAPA), Internal Audits and more. Shilpi Sinha has 2 emails and 1 mobile phone numbers on RocketReach.
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