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 solid quality culture throughout the organization.

📌 Quality Assurance Manager Nagpur
🏢 CURO Biosciences
📍 Nagpur