About the Role
We are seeking motivated professionals to support auditing, documentation, implementation, consultancy, and certification/accreditation activities related to Medical Device Quality Management Systems, Testing & Calibration Laboratories, and Medical Laboratories.
Key Responsibilities
* Participate in Internal, Supplier, and Certification Audits
* Assist in Stage 1, Stage 2, Surveillance, and Recertification Audits
* Prepare audit checklists, audit reports, and NCRs
* Develop Quality Manuals, SOPs, Procedures, Validation Records, and Technical Documentation
* Support ISO implementation, NABL accreditation, and compliance projects
* Conduct gap assessments, corrective action verification, and readiness reviews
* Support client training, awareness programs, and consultancy activities
Preferred Standards Experience
Medical Devices
* ISO 13485:2016 – Medical Device Quality Management Systems
Testing & Calibration Laboratories
* ISO/IEC 17025:2017 – Testing & Calibration Laboratories
Medical Laboratories
* ISO 15189:2022 – Medical Laboratory Quality Management Systems
Educational Qualification
* B.E / B.Tech (Biomedical, Biotechnology, Mechanical, Electrical, Electronics, Chemical, Industrial Engineering)
* B.Sc / M.Sc (Microbiology, Chemistry, Biotechnology, Physics, Life Sciences)
* BMLT / MMLT / Medical Laboratory Technology
* Pharmacy, Biomedical Sciences, Quality Management, or related disciplines
5 - 10 years of experience in Internal Auditors, Laboratory Professionals, QA/QC Executives, Medical Device Professionals, and ISO Consultants are welcome to apply.
Preferred Professional Qualifications
Internal Auditor
* ISO 13485 Internal Auditor
* ISO/IEC 17025 Internal Auditor
* ISO 15189 Internal Auditor
* IMS Internal Auditor
Lead Auditor (Preferred)
* ISO 13485 Lead Auditor
* ISO/IEC 17025 Lead Auditor
* ISO 15189 Lead Auditor
* IRCA/CQI Lead Auditor qualifications
Preferred Experience
* Medical Device Quality Management Systems
* Testing, Calibration, or Medical Laboratories
* NABL Accreditation Projects
* Internal Auditing & Compliance Activities
* ISO Consultancy & Documentation Development
* Quality Assurance / Quality Control
* Regulatory Compliance & Validation Activities
Key Skills
* Audit Planning & Reporting
* Documentation Development
* CAPA & Root Cause Analysis
* Risk-Based Thinking
* Validation & Verification Concepts
* Technical Report Writing
* Communication & Client Coordination
Preferred Candidate Profile
✔ ISO 13485 / ISO 17025 / ISO 15189 Auditor Qualification
✔ Medical Device Industry Experience
✔ Testing, Calibration, or Medical Laboratory Experience
✔ NABL Accreditation Experience
✔ ISO Consultancy Experience
✔ QA/QC or Healthcare Quality Experience
Pay: ₹500,000.00 - ₹600,000.00 per year
Experience:
- Auditing: 5 years (Preferred)
License/Certification:
- ISO Certification (Preferred)
Location:
- Chennai, Tamil Nadu (Chennai, Chennai District) (Preferred)
Work Location: In person
