Job Title

Designation: QA AssociateLocation: GandhinagarExperience: 2+ YearsSalary: Up to 5LPAJob 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 VermaHR RecruiterMantras2Success+91 7227046629