Head of Quality, Ortho Division
11 hours ago
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.
-
Head of Quality, Ortho Division
14 hours ago
Ahmedabad, India Native Full timeHead - Quality, Ortho Division (Medical Devices)Designation: DGM/GMLocation: AhmedabadJob SummaryA 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...
-
Head of Quality, Ortho Division
9 hours ago
Ahmedabad, India Native Full timeHead - Quality, Ortho Division (Medical Devices)Designation: DGM/GMLocation: AhmedabadJob SummaryA 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...
-
Head of Quality, Ortho Division
9 hours ago
Ahmedabad, India Native Full timeHead - Quality, Ortho Division (Medical Devices)Designation: DGM/GMLocation: AhmedabadJob SummaryA 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...
-
Head of Quality, Ortho Division
3 hours ago
Ahmedabad, India Native Full timeHead - 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,...
-
Head of Manufacturing
14 hours ago
Ahmedabad, India Native Full timeHead - Manufacturing, Ortho Division (Medical Devices)Designation: Sr. GMLocation: AhmedabadJob SummaryA leading medical devices organisation is seeking an experienced manufacturing leader to oversee its orthopaedic devices production operations. This role covers multi-site manufacturing leadership, productivity enhancement, cost control, and strict...
-
Head of Manufacturing
9 hours ago
Ahmedabad, India Native Full timeHead - Manufacturing, Ortho Division (Medical Devices)Designation: Sr. GMLocation: AhmedabadJob SummaryA leading medical devices organisation is seeking an experienced manufacturing leader to oversee its orthopaedic devices production operations. This role covers multi-site manufacturing leadership, productivity enhancement, cost control, and strict...
-
Head of Manufacturing
9 hours ago
Ahmedabad, India Native Full timeHead - Manufacturing, Ortho Division (Medical Devices)Designation: Sr. GMLocation: AhmedabadJob SummaryA leading medical devices organisation is seeking an experienced manufacturing leader to oversee its orthopaedic devices production operations. This role covers multi-site manufacturing leadership, productivity enhancement, cost control, and strict...
-
Head of Manufacturing
3 hours ago
Ahmedabad, India Native Full timeHead - Manufacturing, Ortho Division (Medical Devices) Designation: Sr. GM Location: Ahmedabad Job Summary A leading medical devices organisation is seeking an experienced manufacturing leader to oversee its orthopaedic devices production operations. This role covers multi-site manufacturing leadership, productivity enhancement, cost control, and strict...
-
Division Head
5 days ago
Ahmedabad, Gujarat, India Antal International Full timeLocation: Dubai, UAE (the candidate requires to relocate to UAE)Reporting To: CEO/Managing DirectorExperience: Minimum 6 yearsIndustry: Chemicals / Petrochemicals / PlasticizersJob Summary:We are seeking a senior leader to head our newly launched plasticizer division with full P&L responsibility, operational control, sales responsibility and raw material...
-
Regulatory Affairs
2 weeks ago
Ahmedabad, Gujarat, India Biotek Ortho Full time ₹ 12,00,000 - ₹ 36,00,000 per yearCompany DescriptionBiotek Ortho is a global medical device company specializing in cutting-edge innovation within the orthopedic sector, particularly in sports medicine and extremities. With a strong presence across six continents, Biotek continues to experience robust growth and demand for its high-quality products. Despite its global reach, Biotek remains...