Lead Quality Control - Medical Device (Zydus Medtech)

Job description

**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) - Good 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 to OOS, OOT, non-conformances, customer complaints, and product failures. - Drive root cause analysis using quality tools. - Ensure timely implementation and effectiveness of CAPA. - Prepare trend analysis and quality metrics reports. Team Leadership - Lead and develop the QC team, including analysts, inspectors, and laboratory personnel. - Define KPIs and performance objectives. - Conduct training programs on quality systems, laboratory practices, and compliance requirements. - Foster a culture of quality and continuous improvement. Continuous Improvement - Drive Lean, Six Sigma, and Quality Excellence initiatives. - Identify opportunities for process improvement, cost optimization, and laboratory automation. - Establish KPI dashboards and quality performance metrics. Key Accountabilities - Product quality and compliance. - Laboratory performance and efficiency. - Audit readiness and successful regulatory inspections. - Timely closure of investigations and CAPAs. - Reduction in customer complaints and quality deviations. - Team capability development and succession planning. Educational Qualifications - Bachelor's or Master's Degree in: - Biomedical Engineering - Biotechnology - Chemical Engineering - Mechanical Engineering - Polymer Science - Life Sciences - Pharmacy (preferred) Experience Essential - 1015+ years of experience in Quality Control within Medical Devices, Pharma, Healthcare, or Regulated Manufacturing. - Minimum 5 years of leadership experience managing QC laboratories and teams. Preferred - Experience in manufacturing of: - Dialyzers - Blood purification systems - Extrusion/Membrane-based medical devices - Sterile medical devices - Single-use consumable devices Technical Skills - Hemodialyzer performance testing. - Membrane characterization and testing. - Biocompatibility awareness. - Sterility assurance and microbiological testing. - Validation and qualification activities. - Statistical quality control tools. - Risk assessment and investigation techniques. - Good understanding of CAPA, change control, NCR, and complaint handling. Leadership Competencies - Strong people management and coaching skills. - Excellent problem-solving and decision-making ability. - Effective stakeholder management. - High attention to detail and quality mindset. - Strong communication and audit-handling skills. Preferred Certifications - ISO 13485 Lead Auditor - Six Sigma Green Belt / Black Belt - ASQ Certified Quality Manager (CQM) - Certified Quality Engineer (CQE)