Kandukuru Gowthami
Medical Devices|EU MDR|DHF|ISO 13485|ISO 14971|ISO 15223|ISO 10993|Technical Documentation|GSPRC|Verification and Validation activities|Regulatory Affairs|Quality|PMS| Complaint handling| CAPA|
- Role
- Complaint Investigation Specialist at Amgen India
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Kandukuru Gowthami
A Mechanical Engineer working in the field of Medical Device/Healthcare sector 1…
Experience
Complaint Investigation Specialist
Sep 2023 — Present · Hyderabad, IN
Knowledge on Medical Device Regulations such as ISO 13485, 21 CFR 820, 21 CFR 803, ISO 14971 and EU MDR• Analyzing the potential complaints & non-complaints, determines the reportability of complaints and ensure compliance with FDA regulations related to complaint handling, including timely reporting of adverse events and recalls• Experienced in Complaint handling processes (Intake, Reassessment and Investigation)• Writes investigation summaries based on technical product analysis information provided • Experience working collaboratively with cross-functional teams to ensure product safety and customer satisfaction• Efficiently managing & resolving product complaints• Develop and implement corrective & Preventive actions (CAPA) to address identified issues• Experienced in SaMD cases execution, Product Analysis summary reviews, DHR & Medical reviews, performing follow-up with customer for additional information• Organizational activities – Performing internal audits and Quality error reviews
Education
Z.P.H Girls School
S.S.C
Rajiv Gandhi University of Knowledge Technologies, RKValley (RAC)
Bachelor of Technology - BTech
2016 — 2020
Rajiv Gandhi University of Knowledge Technologies, RKValley (RAC)
Pre University Course
2014 — 2016
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