QA Executive – Quality Management System (QMS)

Department: Quality Assurance

Reporting To: QA RA Specialist

Experience:2–5 Years

Industry: Medical Devices / Electronic Medical Devices

Standard: ISO 13485:2016

Job Summary

We are looking for a detail-oriented and compliance-driven QA Executive – QMS to join our Quality Assurance team. The ideal candidate will be responsible for implementing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with ISO 13485:2016 and applicable medical device regulations.

This role involves handling document control, internal audits, CAPA, non-conformance management, complaint handling, and supporting regulatory compliance activities to ensure the delivery of protected and effective medical devices.

Key Responsibilities

- Maintain and improve the Quality Management System (QMS) as per ISO 13485:2016 requirements
- Manage document control activities including SOPs, formats, records, and revisions
- Conduct and support internal audits and follow-up actions
- Handle Non-Conformances (NC), CAPA, deviations, and complaint investigations
- Perform root cause analysis using tools such as 5-Why, Fishbone/Ishikawa, and FMEA
- Support regulatory compliance activities related to CDSCO, EU MDR, and FDA requirements
- Collaborate with cross-functional teams including R&D;, Manufacturing, and Regulatory Affairs
- Ensure proper maintenance of quality records and audit readiness
- Participate in continuous improvement initiatives and quality training activities

Qualifications

- BE/BTech in Biomedical Engineering,



Life Sciences, or related field
- 2–5 years of experience in Quality Assurance / Regulatory Affairs within the medical device industry
- Experience in electronic medical devices is mandatory
- Good understanding of ISO 13485:2016 requirements

Exposure to:

- US FDA 21 CFR Part 820
- CDSCO Medical Device Rules 2017
- EU MDR 2017/745
- ISO 13485 Internal Auditor certification will be an added advantage

Required Skills

- Strong knowledge of document control processes
- Experience in handling NC, CAPA, and complaint management
- Familiarity with risk management concepts (ISO 14971)
- Awareness of IEC 62304 medical device software lifecycle standards is preferred
- Strong written communication skills for SOPs, audit reports, and regulatory documentation
- Good analytical and problem-solving abilities
- Attention to detail and strong compliance mindset
- Proficiency in MS Office; knowledge of Minitab or statistical tools is a plus

Desirable Add-ons

Candidates with exposure to below will be given preference

- Sterile device manufacturing
- Electronic medical devices
- Combination products
- CDSCO QMS inspection requirements

Pay: ₹25,000.00 - ₹40,000.00 per month

Benefits:

- Paid time off
- Provident Fund

Application Question(s):

- Current CTC
- Expected CTC
- Do you have experience in electronic medical devices?
- Do you have BE/BTech in Biomedical Engineering, Life Sciences, or related field?

Education:

- Bachelor's (Required)

Experience:

- QA: 2 years (Required)

Work Location: In person

📌 Quality Assurance Executive – Quality Management System (India)
🏢 Gadgeon Medical Systems
📍 India