Lead Auditor

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