Quality Assurance Manager - Medical Devices

Syrma Johari Medtech

10 - 15 years

10 - 18 Lacs

jodhpur

Posted:2 days ago| Platform:

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Skills Required

internal audit iso 13485 qms electronics medical devices medical equipment

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 14971) and validation lifecycle

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