💼 Full-Time Position

Lead Auditor

🏢
Sofomation
📍 Gandhinagar, Gujarat, India
📍
Location
Gandhinagar, India
📅
Posted
May 30, 2026
Type
Full-Time
🎯

Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

Job Description

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 **