Quality Assurance Manager

2 days ago


Jodhpur, Rajasthan, India Syrma Johari Medtech Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

  • Proven experience in Quality Assurance, specifically in medical device manufacturing regulated under ISO 13485, 21 CFR Part 820, and EU MDR.
  • Prior experience in leading audits (US FDA, Notified Body, CDSCO), and QMS implementation from scratch.

  • Lead and manage the Quality Assurance function, ensuring compliance with applicable national and international regulations and standards.

  • Ensure QMS compliance as per ISO 13485:2016, 21 CFR Part 820, and MDR 2017/745 requirements.
  • Review and approve quality documentation SOPs, DHRs, DHFs, QMS procedures, and validation protocols.
  • Act as Management Representative (MR) for external audits and regulatory inspections (US FDA, NB audits, CDSCO).
  • Lead CAPA, Non-conformance investigations, Risk Management (ISO 14971), and Change Control processes.
  • Oversee supplier qualification and audit programs, ensuring robust external quality management.
  • Review and monitor key QA metrics complaint trends, batch release, and internal audit results.
  • Drive continuous improvement initiatives within QA and cross-functional quality forums.
  • Mentor and develop the QA team through training, goal setting, and performance reviews.

Preferred candidate profile

  • Deep understanding of ISO 13485, 21 CFR 820, EU MDR, and Indian MDR (2017)
  • Hands-on experience with CAPA, Deviations, Audit handling, QMS software (e.g., Master Control, Veeva)
  • Sound knowledge of risk management (ISO and validation lifecycle


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