QA Associate

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.