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Lead Auditor

Company

Sofomation

Location

Sangli, Maharashtra

Posted

June 02, 2026

Position Overview

OPENING FOR A WELL KNOWN TIC COMPANY In INDIA

Minimum Requirements:

must have 10 years of professional experience in the medical device industry with at least 4 years in the design, manufacturing, testing.


Roles & Responsibilities

  • Auditing Quality Management Systems (mainly ISO 13485).
  • Checking compliance with regulations (e.g., EU MDR, FDA 21 CFR 820, MDSAP).
  • Assessing technical documentation, validation, and product safety evidence.
  • Experience with Risk Management EN ISO 14971;
  • Qualified MDR Assessor from a reputed EU Notified Body, desirable


**Interested Candidates Can Apply Or Share Your Updated CV on **

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