Manager QA

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 14971) and validation lifecycle

Job Type: Full-time

Pay: Up to ₹3,000,000.00 per year

Work Location: In person