Head - Quality, Ortho Division (Medical Devices)
Designation: DGM/GM
Location: Ahmedabad
Job Summary
A recognised medical devices manufacturer is looking for a Quality leader to oversee QA, QC, and compliance activities for its orthopaedic devices portfolio. This position ensures products and processes meet global regulatory expectations including ISO 13485, FDA QSR, EU MDR, and CDSCO requirements. The role focuses on strengthening process validation, managing site audits, leading QC operations, and supporting design transfer and NPI initiatives.
Key Responsibilities
- Lead the QMS for the Ortho Division and align with all applicable global and local regulatory standards.
- Oversee internal audits, management reviews, inspection readiness, and external assessments.
- Direct QA/QC processes for incoming materials, machined components, in-process assemblies, and final products.
- Ensure sterilisation validation, process validations, equipment calibration, and adherence to risk management protocols.
- Track and improve KPIs such as rejection rates, defects, customer complaints, and yield performance.
- Coordinate closely with Manufacturing Head to ensure production meets quality benchmarks.
- Partner with Regulatory Affairs, NPI, Procurement, and Design teams on submissions, supplier quality and design transfer activities.
- Lead and develop QA/QC teams across sites; drive training in GMP, QMS, and quality tools.
- Promote a culture of continuous improvement, quality integrity, and proactive risk mitigation.
Qualifications
- 15 -18 years of experience in quality functions, including senior leadership responsibilities.
- Strong background in medical device manufacturing, ideally orthopaedic implants/instruments.
- Bachelor's degree in mechanical, Biomedical or Industrial Engineering; master's or quality certifications preferred.
- Strong understanding of ISO 13485, FDA QSR, EU MDR, validation, process controls, and documentation systems.
- Proficiency in reviewing and managing quality documentation, ERP systems and investigative tools.
- Strong leadership, collaboration and analytical skills.
