Masters (Regulatory Affairs and Quality Assurance)
2007-2009
University of Mumbai
Bachelors (Biomedical Engineering)
2001-2006
Pratik Sheth Skills
21 CFR
21 CFR 820
AIMDD
Auditing
Biomedical Engineering
CAPA
CMDR
Certified Internal Auditor
Contract Negotiation
Corrective Actions
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
DMAIC
Design Assurance
Design Control
Design for Manufacturing
FDA
GMP
ISO 13485
ISO 14971
ISO Standards
Internal Audit
JPAL
Medical Devices
Problem Solving
Production Part Approval Process (PPAP)
Quality Assurance
Quality Auditing
Quality Control
Quality Engineering
Quality System
Regulatory Affairs
Risk Management
Supplier Development
Supplier Quality Management
Verification and Validation (V&V)
Quality Engineer
Cross Functional Team Leadership
Pratik Sheth Summary
Pratik Sheth, based in United States, is currently a Senior Manager, Supplier Quality at Edwards Lifesciences. Pratik Sheth brings experience from previous roles at Johnson & Johnson MedTech, Edwards Lifesciences, Allergan Aesthetics, an AbbVie Company and Advanced Bionics. Pratik Sheth holds a 2007 - 2009 Masters in Regulatory Affairs and Quality Assurance @ University of Southern California. With a robust skill set that includes 21 CFR, 21 CFR 820, AIMDD, Auditing, Biomedical Engineering and more. Pratik Sheth has 3 emails and 2 mobile phone numbers on RocketReach.
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