QA Associate

1 week ago

Gandhinagar Gujarat India, Gujarat Mantras2Success.com Full time

Designation: QA Associate

Location: Gandhinagar

Experience: 2+ Years

Salary: Up to 5LPA


Job Profile:

  • 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.



Thanks & Regards,

Rishita Verma

HR Recruiter

Mantras2Success

+91 7227046629

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