Manager QA
1 week ago
Job Description
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.
Required Experience
10-14 Years 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.
Required Qualification Bachelor's degree in Engineering Electronics - B.E/B.Tech)
Additional certifications (e.g., Lead Auditor – ISO 13485, Six Sigma,
Regulatory Affairs) will be an advantage
Specific Job Skills Required:
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
Job Type: Full-time
Pay: Up to ₹3,000,000.00 per year
Work Location: In person
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