Role & responsibilities

- Lead and manage the Quality Assurance department.

- Ensure compliance with ISO 13485, GMP, FDA 21 CFR Part 820/QMSR, MDR, and applicable regulatory requirements.

- Develop, implement, and maintain the Quality Management System (QMS).

- Handle internal, customer, certification body, and regulatory audits.

- Review and approve Standard Operating Procedures (SOPs), specifications, protocols, and quality documents.

- Drive Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), and Change Control processes.

- Perform Root Cause Analysis using quality tools such as 5 Why, Fishbone Diagram, and 8D methodology.

- Monitor Key Performance Indicators (KPIs) related to quality and implement improvement initiatives.

- Lead Management Review Meetings and Quality Review Meetings.





- Ensure supplier quality management and support supplier qualification activities.

- Collaborate with Production, R&D;, Regulatory Affairs, Engineering, and Supply Chain teams.

- Support process validation, equipment qualification, and product validation activities.

- Ensure complaint handling, market feedback review, and quality risk management activities.

- Maintain documentation for regulatory inspections and customer audits.

- Lead quality improvement projects to reduce rejection, rework, and customer complaints.

- Train employees on quality systems, GMP, and regulatory requirements.

📌 Quality Manager (Faridabad)
🏢 Polymed
📍 Faridabad