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, maintaining a h
📌 Medical Device Assessor (New Delhi)
🏢 DNV
📍 New Delhi