QA & RA Associate Mantras2success Consultants

0.0 - 4.0 years

3 - 7 Lacs

Ahmedabad, Gujarat, India

On-site

Key Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016. Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745. Review certificates of analysis (COA), sterilization check sheets, calibration reports, and oth...

Posted 1 month ago

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