Prachit Salunke
Design Quality Engineer | Medical Device Regulatory | 21 CFR 820, EU MDR, & ISO Standards | QMS, Change & Risk Management | Cross-Functional Team Leader with Global Exposure
- Role
- Qms Manager at Philips
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Prachit Salunke
As a highly disciplined and innovative Medical Device professional, I bring nearly five years of experience overseeing cross-functional teams and leading Continuous Improvement, Global Regulatory compliance, and maintaining Quality Management Systems (QMS). My expertise includes Change Management, Risk Management, and Lean Manufacturing initiatives, where I have successfully integrated Lean techniques into everyday tasks with short and long-term goals.My strong analytical skills have made me an expert in Gap analysis, Root-Cause analysis, Corrective and Preventive Action (CAPA), Design Control, Verification Reports, Document Control, and Change Control. I possess excellent working knowledge of Global Regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, 14971, 15223 & 15378, which has enabled me to maintain compliance with regulatory standards.I strive for excellence in the Medical Device industry, ensuring quality products and regulatory compliance.
Experience
Qms Manager
May 2024 — Present · Pune, IN
Education
Wayne State University
Master's degree, Mechanical Engineering
2015 — 2017
Savitribai Phule Pune University
Bachelor's degree, Mechanical Engineering
2010 — 2014
Skills
- Combustion Systems
- Microsoft Office
- Automotive Engineering
- Etas Inca
- Matlab
- Emissions Trading
- Chemkin
- Simulink
- Fluid Mechanics
- Ansys
- Combustion Analysis
- Labview
- Proe
- Calibration
- Autocad
- Computational Fluid Dynamics (Cfd)
- Mastercam
- Gt-Power
- Design of Experiments
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