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🥝 Medical Device Auditor

DNV | Vadodara, India | Posted May 24, 2026

Job Description

As part of our continued growth, we are looking to recruit technical and experienced Medical Device Assessors/Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/745 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Scope


A Medical Device Auditor evaluates whether medical device companies comply with regulatory requirements and quality standards. 

  • Auditing Quality Management Systems (mainly ISO 13485).
  • Checking compliance with regulations (., EU MDR, FDA 21 CFR 820, MDSAP).
  • Assessing technical documentation, validation, and product safety evidence.
  • Reporting nonconformities, recommending corrective actions, and ensuring follow‑up.
  • Work collaboratively with cross‑function...
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