Vignesh Kumar Sakthivel Email & Phone Number | Diligent Mechanical Engineer with 6+ years of experience with zest precise to make a prolonged development-oriented career in the medical devices domain. Specialized in medical device regulatory affairs and quality management with a proven track record. Skilled in Post-Market Surveillance, design control, RoHS, and QMS for medical devices. Experienced in investigating complaints, remediating DHF, and complying with label requirements. Proficient in surgical instruments, orthopaedic implants and medical devices Have extensive knowledge of regulations and standards such as ▪️EU MDR 2017/745 - GSPR and Technical Documentation - Technical Documentation on Post Market Surveillance ▪️US FDA 21 CFR - 801 ~ Labeling - 803 ~ Medical Device Reporting - 806 ~ Medical Device Corrections and Removals - 807 ~ Establishment Registration and Device Listing For Manufacturers and Initial importers of Devices - 820 ~ Quality System Regulation ▪️ISO 13485 ~ Medical Device - Quality Management System ▪️ISO 14971 ~ Application of risk management to Medical Devices ▪️ISO 15223 ~ Symbols to be used with medical device labels

Vignesh Kumar Sakthivel

Diligent Mechanical Engineer with 6+ years of experience with zest precise to make a prolonged devel...
Tiruchirappalli, Tamil Nadu, India

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Vignesh Kumar Sakthivel’s Email vignesh.sakthivel@cyient.com

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Vignesh Kumar Sakthivel’s Location Tiruchirappalli, Tamil Nadu, India

Vignesh Kumar Sakthivel’s Current Industry Cyient

Vignesh Kumar Sakthivel’s Prior Industry Hcl Technologies | Renault Nissan Automotive

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Quality Assurance Specialist

2022-05-01 00:00:00 - Present

QARA Engineer

2019-01-01 00:00:00 - 2022-04-01 00:00:00

Graduate Apprentice Trainee

2016-10-01 00:00:00 - 2017-10-01 00:00:00

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Vignesh Kumar Sakthivel is a Diligent Mechanical Engineer with 6+ years of experience with zest precise to make a prolonged development-oriented career in the medical devices domain. Specialized in medical device regulatory affairs and quality management with a proven track record. Skilled in Post-Market Surveillance, design control, RoHS, and QMS for medical devices. Experienced in investigating complaints, remediating DHF, and complying with label requirements. Proficient in surgical instruments, orthopaedic implants and medical devices Have extensive knowledge of regulations and standards such as ▪️EU MDR 2017/745 - GSPR and Technical Documentation - Technical Documentation on Post Market Surveillance ▪️US FDA 21 CFR - 801 ~ Labeling - 803 ~ Medical Device Reporting - 806 ~ Medical Device Corrections and Removals - 807 ~ Establishment Registration and Device Listing For Manufacturers and Initial importers of Devices - 820 ~ Quality System Regulation ▪️ISO 13485 ~ Medical Device - Quality Management System ▪️ISO 14971 ~ Application of risk management to Medical Devices ▪️ISO 15223 ~ Symbols to be used with medical device labels