Thirugnanavignesh Appuchamy
Immediate joiner | Lead Engineer - PMS Complaint handling | ISO 13485,ISO 14971 | 21 CFR 820 | EU MDR 2017/745 ,US FDA
- Role
- Lead Engineer at HCLTech
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Thirugnanavignesh Appuchamy
Global Complaint Handling and Vigilance Reporting Specialist with 4+ years in Medical…
Experience
Lead Engineer
Mar 2021 — Present · IN
Evaluated incoming complaint information and maintain the record in the electronic database.• Gathered additional information from complainants through systematic follow-ups to ensure thorough investigations.• Determination of Reportability of complaints to Government Agencies.• Work to Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.• Prepared investigation summaries based on technical product analysis information provided.• Ensured record documentation is maintained in a constant state of audit readiness per internal policies.• Liaison with groups who perform additional investigations and who prepare a written record of the• investigation.• Provided basic technical expertise and assisted in handling complaints to comply with current FDA and International reporting regulations.• Have Interacted with multiple departments within Clients -such as Technical Services, Failure Investigation, R&D, Manufacturing, and Engineering.• Interacted with groups external to Client - such as customers, vendors, Health care professionals.
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