Company: Zydus MedTech
Division: Medical Devices Dialyzer Manufacturing
Location: [Plant Location]
Department: Quality Control (QC)
Reporting To: Site Head

Position Summary

The Manager QC / QC Head will be responsible for leading and managing the Quality Control function for the manufacturing of hemodialyzers and related medical devices. The role ensures compliance with applicable regulatory requirements, quality standards, and product specifications while maintaining the highest standards of patient safety and product quality. The incumbent will oversee incoming, in-process, and finished product testing, laboratory operations, method validation, investigations, and continuous quality improvement initiatives.

Key Responsibilities

Quality Control Operations
- Establish, implement, and maintain a robust Quality Control system for dialyzer manufacturing.
- Manage incoming raw material testing, in-process inspections, and finished product release activities.
- Ensure timely testing and disposition of raw materials, components, packaging materials, and finished goods.




- Review and approve test reports, CoAs, protocols, and quality records.
- Monitor laboratory efficiency, testing turnaround times, and compliance with established procedures.

Laboratory Management
- Oversee physical, chemical, biological, microbiological, and performance testing of dialyzers.
- Ensure calibration, qualification, and maintenance of laboratory equipment and instruments.
- Develop and validate analytical and inspection methods as per regulatory requirements.
- Ensure proper laboratory documentation and data integrity practices.

Regulatory & Compliance
- Ensure compliance with:
- ISO 13485
- Medical Device Rules (India)
- EU MDR (preferred)
- Positive Manufacturing Practices (GMP)
- ISO 14971 Risk Management requirements
- Support regulatory inspections and customer audits.
- Act as a key representative during internal and external audits.

Investigation & CAPA
- Lead investigations related

📌 Lead Quality Control (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad