QA Associate

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