VINOTHKUMAR ARUNACHALAM
Vigilance Specialist
Madurai, Tamil Nadu,
Summary
Profile Summary
- 5 years of experience as a Vigilance Specialist, Technical Writer in the Medical Device Industry and Quality Assurance Trainee in the Automotive Industry.
- Expertise in submission of medical device reports to the FDA through the Trackwise tool.
- Reviewed, evaluated, and classified product complaints based on identity, quality, reliability, safety, and effectiveness of medical devices.
- Conducted thorough investigations and analysis to determine reportability to government agencies, ensuring compliance with FDA and International reporting regulations.
- Prepared investigation summaries based on technical product analysis information provided by the plant, maintaining accuracy and audit readiness.
- Proficient in complaint handling procedures and regulatory compliance (FDA, MEDDEV, Canadian Regulations).
Overview
2
2
years of professional experience
2
2
Certifications
Work History
Software Engineer (Including a 6-month Internship)
HCLTECH
03.2021 - 3 2024
- Gathered and analyzed data related to device failures and patient impact for regulatory reporting.
- Conducted complaint investigations, determined root causes, and recommended CAPAs.
- Expert in submission of eMDR and generation of adverse event reports for FDA.
- Strong industrial knowledge on FDA 21 CFR 820.198, 803, and Medical Device Regulation Canada SOR/98-282.
- Developed and maintained Summary of Technical Documentation (SteD) files for EU Notified Body Submission.
- Worked closely with cross-functional teams to address product or service concerns raised by customers.
- Interacted with all stakeholders to clarify scope of work.
Quality Assurance Trainee
Gestamp Automotive Chennai Pvt Ltd
09.2017 - 09.2019
- Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
- Recorded product and process characteristics of projection welding machines, providing essential data for reporting purposes and ongoing process improvements.
- Addressed non-conformance issues, pausing production to correct errors.
- Participated in root cause analysis to identify and address recurring issues, improving overall quality levels.
Education
Bachelor of Engineering - Mechanical Engineering
NPR College of Engineering And Technology
Dindigul, India 04.2001 -
HSS -
SDA Matriculation Higher Secondary School
Madurai, India 04.2001 -
Skills
Track Wise 9
undefinedCertification
Understanding How Medical Devices are Regulated in Canada offered by Health Canada.
Accomplishments
HCLTech:
- Automated data gathering for complaint handling, reduces project time.
- Implemented a user-friendly system for tracking and managing incoming complaints, boosting overall productivity within the team.
Gestamp Automotive Chennai Private Limited:
- Improved weld strength in projection welding machine to arrest bolt failure by 8D methodology.
- Identified issues to increase productivity and boost workflow.
Timeline
Software Engineer (Including a 6-month Internship)
HCLTECH
03.2021 - 3 2024
Quality Assurance Trainee
Gestamp Automotive Chennai Pvt Ltd
09.2017 - 09.2019
Bachelor of Engineering - Mechanical Engineering
NPR College of Engineering And Technology
04.2001 -
HSS -
SDA Matriculation Higher Secondary School
04.2001 -
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