Karthikaisamy K

SaMD complaints| Medical device Application investigation|Post Market Surveillance | Complaint Handling Specialist | Medical Device Reporting | Sustenance Engineering| Design Control|DHF & DMR| Customer Quality|

Role
Senior Associate at Amgen India
Location
Madurai, TN, IN
LinkedIn followers
500 followers

About Karthikaisamy K

I\'ve got over nine years in medical devices.I\'m really familiar with complaint handling (21 CFR 820.198), medical device reporting (21 CFR 803), and recalls, corrections, and removals (21 CFR 806).I possess expertise in TrackWise and SmartSolve, and am experienced with SolidWorks.I\'ve got solid experience in medical device sustaining engineering, DHF remediation, and fixture design, plus handling complaints.Hands-on experience with 3D printing.

Experience

  1. Senior Associate

    Amgen India

    May 2025 — Present · IN

Education

  • SACS MAVMM Engineering College, Madurai

    Bachelor of Engineering - BE, Mechanical Engineering

    2012 — 2015

  • Latha Mathavan polytechnic College

    Diploma in mechanical, Mechanical Engineering

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Karthikaisamy K — Senior Associate at Amgen India in Madurai, TN, IN | Unifers