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Mantras2Success Consultants
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QA & RA Associate
Mantras2Success Consultants
posted 5mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- Documentation Executive
- Qa
- Regulatory Affair
Employment Type: Full Time, Permanent
Functional Areas: Manufacturing
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Mantras2Success Consultants Benefits
Work From Home 
Job Training 
Team Outings 
Education Assistance 
Soft Skill Training 
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