Gokul M

Experience

1. Lead Engineer

   HCLTech

   Sep 2022 — Present

   PMS - Medical device compliance • SME on Medical devices – Handled 10 different business Units with multiple products• SME on manual complaints, Journal and article complaints, Drug complaints, regulatory complaints• Worked for Latin American region complaints from Intake, DT and Follow up with customer for critical requirements for investigation.• MDR submission for US FDA, EU MDR adverse events.• Investigation on reported events and preparing Investigation summary.• Involved in process improvements and time analysis activities.• Manual QC Check for the files performed by the team to avoid errors which leads to late reporting• Handling SCAR, CAPA, 5 why analysis.• Providing awareness session on CAPA, implementing corrective action to avoid recurrence.• Performing Risk analysis and internal audit• Handling ANVISA, Complaints• Performed retrospective review for the closed records• Performed GAP analysis on SOP• Worked on creating Standard Work Instruction for the Region.Creating SOP for regions as per GWIISO 13485Verification and Validation -Reviewing the client documents adhered to ISO norms.Engineering change management – Requesting for changes to client in the drawing, initiating changes by implementing change notice and follow up.

Education

• Dhanalakshmi Srinivasan College of Engineering

  Bachelor of Engineering - BE

  2013 — 2017