Sofomation
Website:
sofomation.com
Job details:
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 gautam@sofomation.com**
Click on Apply to know more.