Head of Quality, Ortho Division (Medical Devices)

15 - 18 years

0 Lacs

ahmedabad gujarat india

Posted:5 days ago| Platform: Linkedin logo

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Skills Required

qc compliance portfolio mdr audits design management inspection calibration risk manufacturing procurement drive training integrity leadership engineering certifications controls documentation erp collaboration

Work Mode

On-site

Job Type

Full Time

Job Description

Head - Quality, Ortho Division (Medical Devices)

Designation:

Location:


Job Summary

ISO 13485, FDA QSR, EU MDR, and CDSCO


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.

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