Shilpi Sinha Email & Phone Number
Head of Quality Assurance and Regulatory Affairs @ Magnolia Medical Technologies
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Shilpi Sinha Location
- Seattle, WA, US
Shilpi Sinha Work
- Head of Quality Assurance and Regulatory Affairs @ (May 2025 - Present)
- Head of Quality and Regulatory Affairs @ (May 2023 - September 2025)
- Director Quality Assurance @ (May 2013 - May 2023)
- Quality Assurance Director @ (May 2013 - May 2023)
- Quality and Regulatory Affairs Manager @ HemoCue Inc, Quest Diagnostics (October 2012 - April 2013)
- Quality Systems Manager @ Focus Diagnostics,Quest Diagnostics (January 2007 - October 2012)
- QA and Regulatory Affairs Manager @ Peptisyntha Inc.( A Solvay America Company) (January 2005 - January 2007)
- Quality Process Compliance Manager @ Solvay Draka ( A Solvay America Company) (January 2002 - January 2005)
- Quality Officer @ Aventis (January 1997 - January 2001)
Shilpi Sinha Education
- Regulatory Affairs Professional Society (RAPS)
Regulatory Affairs Certification
-
Masters (Microbiology)
- ASQ - CMDA
Certified Medical Device Auditor also known as Certified Biomedical Auditor
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 Regulatory Affairs Certification @ Regulatory Affairs Professional Society (RAPS). 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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