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 (e.g., 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‑functional and customer‑facing teams to ensure audit outcomes strengthen relationships and build confidence.




- Communicate findings clearly and professionally to enhance credibility and reinforce the organization’s quality promise to customers.
- Coordinates effectively with cross‑functional stakeholders to ensure timely delivery of outcomes while maintaining the highest levels of customer satisfaction.
- Ensures accurate, error‑free audit report submission and collaborates with GCU for timely review and approval.
- Supports the sales team with technical insights, quality‑related inputs, and customer‑focused information to strengthen proposals, enhance customer confidence, and drive successful deal closures.
- Maintains required auditor credentials/qualifications and proactively pursues continuous advancement of relevant certifications to support high‑quality audits and customer success.

Key Accountabilities: Assessor/Auditor
- Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintai

📌 Medical Device Assessor (Bengaluru)
🏢 DNV
📍 Bengaluru