Niharika Yadav
Design Quality Engineer at Abiomed| Medical devices| Biotechnology| Clinical Research
- Role
- Design Quality Engineer at Johnson & Johnson MedTech
- Location
- Revere, MA, US
- LinkedIn followers
- 500 followers
About Niharika Yadav
Quality Professional with progressive experience in the Medical Device industry.Diverse experience working with FDA Class I, Class II and Class medical devices with associated DHFs, PMAs, EUAs (FDA), and Interim Orders as well as EU Class I, Class IIa /IIb, and Class with associated technical documentation including technical files and design dossiers.Product Experience Includes: Surgical instruments with and without electrical systems, Orthopedic implants, orthotic braces, Sutures and StimulatorsKnowledge ranging in Design Control, Risk Management, Design Quality / Design Assurance, New Product Development, Supplier Quality, Usability, Biocompatibility, Statistical Techniques, Gamma Sterilization, Sterile Packaging, Design Verification & Validation, Root Cause Analysis, QMS; FDA, EU MDR compliance.Various Roles Include: Complaint handling, MDR reporting, product failure analysis, quality systems engineer, supplier quality and design quality engineer.
Experience
Design Quality Engineer
Jun 2023 — Present · Danvers, MA, US
Danvers, Massachusetts, United States
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