Co-Founder at Mantras2success
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Associate - Quality Assurance (1-6 yrs)
Description:
- Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements.
- Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance.
- Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists.
- Participate in internal audits and assist with audit documentation and follow-ups.
- Maintain and update records for compliance with ISO 13485:2016 and cGMP guidelines.
- Assist in the preparation of technical files, labeling, and other product documentation as per EU MDR 2017/745.
- Perform basic quality control tasks, including sample testing and maintaining lab instruments.
- Support microbiological testing, media preparation, and water testing processes.
- Help manage complaint investigations and contribute to implementing corrective and preventive actions.
- Conduct training sessions on SOPs and quality procedures with supervision.
- Stay informed of relevant regulatory changes and assist in updating documents accordingly.
- Assist in compiling data for site master files, device master files, and regulatory reports.
Company Profile:
One of the leading manufacturers of surgical appraratus especially in the Opthalmic field. One of the biggest IOL Manufacturer from INDIA.
Rishita Verma
HR Recruiter
Mantras2Success
+91 7227046629
