QA & RA Associate

Job Description:

Quality Assurance Specialist Responsibilities:

• 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.