Sarita Gulkotwar
Medical Device Professional
- Role
- Senior Quality Engineer at Intuitive
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Sarita Gulkotwar
Certified Quality Engineer (CQE) by ASQ - Certified QMS Internal Auditor of ISO 13485:2016 by-Oriel Stat A Matrix- Experience with QMS models including ISO 13485, FDA’s Quality System Regulation- Experience participating in and leading regulatory audits- Experience with Medical device Reprocessing Validation, EO Sterilization Validation, & Cleanroom Qualification- Process, Test method, and Equipment validation/qualification- Experience with Minitab Statistical software, Design of Experiments, ANOVA Gauge R&R, Process Capability and Performance Analysis, Statistical Process control Techniques, FMEA, Non-conforming material/event handling, CAPA.
Experience
Senior Quality Engineer
Sep 2024 — Present
Education
Mumbai University Mumbai
Bachelor of Engineering - BE, Biomedical/Medical Engineering
San José State University
Master of Science - MS, Medical Devices
Skills
- Microsoft Office
- Medical Devices
- Capa
- Corrective and Preventive Action (Capa)
- Biomaterials
- Fmea
- R&D
- Iso 13485
- Quality System
- Minitab
- Sem
- Design of Experiments
- Biomedical Engineering
- Mechanical Testing
- Solidworks
- Validation
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