Medical Device Auditor
DNV is seeking an experienced Medical Device Auditor to conduct assessments and certification services within the healthtech sector. The role involves auditing quality management systems, verifying compliance with international standards like ISO 13485 and EU MDR, and reporting nonconformities. Candidates must have deep industry experience in medical devices, specifically ophthalmic products, and a strong background in technical documentation and risk management. The position contributes to global safety and sustainability by bridging trust gaps in medical device lifecycles.
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Experience
10+ years
Function
Operations
Work mode
Hybrid, India
Company
Tier 2
What you will work on
DNV is seeking an experienced Medical Device Auditor to conduct assessments and certification services within the healthtech sector. The role involves auditing quality management systems, verifying compliance with international standards like ISO 13485 and EU MDR, and reporting nonconformities. Candidates must have deep industry experience in medical devices, specifically ophthalmic products, and a strong background in technical documentation and risk management. The position contributes to global safety and sustainability by bridging trust gaps in medical device lifecycles.
TAL's take
Solid professional role in a recognized global assurance organization with clear regulatory and compliance responsibilities.
The JD is extremely well-defined with specific regulatory standards and experience requirements mapped directly to the role.
Must haves
- Technical college degree or post graduation in relevant stream
- 10 years professional experience in medical device industry
- 4 years experience in design, manufacturing, testing, or use of ophthalmic devices
- Experience in quality management system and production process for medical devices
- Practical experience conducting or assessing performance evaluation data
Tools and skills
Nice to have: en iso 14971, harmonized standards.
About the company
DNV is a global assurance and risk management firm with deep expertise in certification but does not meet the criteria for global top-tier tech/software companies.