Thiru Gnana Sampath Kumar V.
#Medical Device #Manufacturing Engineer
- Role
- Project Lead at L&T Technology Services
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Thiru Gnana Sampath Kumar V.
Manufacturing Engineer within Medical Device Global Operations Innovation organization…
Experience
Project Lead
May 2021 — Present · Chennai, IN
Act as a Manufacturing Consultant for a leading medical device company, supporting manufacturing operations across the US, China, and Europe regions.Lead process validation and equipment validation activities, ensuring compliance with FDA GMP, 21 CFR, and other regulatory requirements.Provide expertise in validation engineering, process capability analysis, and the Production Part Approval Process (PPAP).Drive continuous improvement initiatives, including Lean Manufacturing, 5S implementation, and Design of Experiments (DOE).Develop and review work instructions, process validation protocols, and manufacturing documentation in compliance with GMP and Medical Device Regulations (MDR).Utilize tools like Agile,Windchill, SIPOC, Minitab and Statistical Process Control (SPC) to optimize manufacturing processes and ensure quality standards.Provide technical project leadership, managing project estimation, timelines, and deliverables for manufacturing engineering projects.
Education
Bharathiar University
Master of Business Administration - MBA
2007 — 2009
State Borad
Higher Secoundary
1995 — 2002
Anna University
Bachelor's degree
2002 — 2006
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