Role Summary:
We are seeking an experienced and meticulous QA/QC Manager to oversee and implement our quality assurance and quality control processes for medical devices and equipment manufactured and distributed in India. The ideal candidate will ensure compliance with national and international regulatory standards, drive continuous improvement, and maintain the highest levels of product quality and safety.

Key Responsibilities:

1. Develop, implement, and maintain the Quality Management System (QMS) in accordance with applicable regulations (e.g., CDSCO, ISO 13485).
2. Lead and manage the QA/QC team, providing guidance, training, and performance management.
3. Oversee all aspects of quality control, including incoming material inspection, in-process inspection, and final product testing.
4. Conduct internal audits and support external regulatory audits.
5. Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
6. Ensure compliance with product labeling, packaging, and sterilization requirements.
7. Collaborate with R&D, Manufacturing, and Supply Chain teams to ensure quality is built into products from the design phase.
8. Monitor and analyze quality metrics, identifying trends and implementing improvement initiatives.
9. Stay updated with the latest regulatory requirements and industry best practices.