Job 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.

📌 QA Associate (Gandhinagar)
🏢 Mantras2Success
📍 Gandhinagar