Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS).
Conduct internal quality audits and participate in management review meetings.
Handle investigations of complaints and implement corrective and preventive actions.
Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016.
Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745.
Review certificates of analysis (COA), sterilization check sheets, calibration reports, and other relevant documents.
Oversee microbiology and quality control activities, including water testing, media preparation, and instrument operation.
Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory requirements.
Prepare and maintain site master files and device master files in compliance with Indian MDR.
Conduct training sessions on quality-related topics.
Stay updated on regulatory changes, including EU MDR requirements.
Assist in the preparation of clinical evaluation reports, risk management analyses, and other regulatory documents.
Review and update quality manuals, device master files, and other essential documents for compliance.