Lead Auditor
Sofomation • Mumbai, Maharashtra • Posted May 30, 2026
About the Role
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 [email protected]**
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 [email protected]**