Role & responsibilities

- Lead and maintain the Quality Management System (QMS) in accordance with ISO 13485:2016.
- Ensure compliance with Medical Device Rules (MDR 2017), CDSCO regulations, and applicable statutory requirements.
- Develop, review, approve, and maintain SOPs, Work Instructions, Specifications, Quality Manuals, and controlled documents.
- Manage incoming, in-process, and final product quality activities.
- Review and approve Batch Manufacturing Records (BMR), Device History Records (DHR), and quality documentation.
- Lead investigations for deviations, non-conformities, customer complaints, and implement effective CAPA.
- Conduct Root Cause Analysis using appropriate quality tools.
- Plan, conduct, and oversee internal audits and coordinate external, customer, certification, and regulatory audits.
- Support regulatory inspections and ensure timely closure of audit observations.
- Monitor quality metrics, KPIs,



and prepare quality performance reports for Management Review Meetings.
- Implement Risk Management activities in accordance with ISO 14971.
- Ensure supplier qualification, vendor audits, and supplier performance monitoring.
- Ensure calibration, validation, qualification, and change control activities are performed as per procedures.
- Coordinate employee training programs related to QMS, GMP, GDP, and regulatory compliance.
- Support current product development and technology transfer activities from a quality perspective.
- Promote continuous improvement initiatives to enhance product quality, process efficiency, and regulatory compliance.
- Supervise and mentor the Quality Assurance team while fostering a strong quality culture throughout the organization.

📌 Quality Assurance Manager (Nagpur)
🏢 CURO Biosciences
📍 Nagpur