Req ID: 391809

NTT DATA strives to hire exceptional, cutting-edge and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Supplier Quality Auditor Subject Matter Expert (SME) - Medical Devices to join our team in Bangalore, Karnātaka (IN-KA), India (IN).
Job Description – Supplier Quality Auditor Subject Matter Expert (SME) – Medical Devices

Experience: 10+ Years
Domain: Healthcare / Life Sciences / Medical Devices / IVD / Combination Products
Function: Supplier Quality, Quality Assurance & Regulatory Compliance

Position Summary

We are seeking a highly experienced Supplier Quality Auditor Subject Matter Expert (SME) with 10+ years of experience in Healthcare/Life Sciences, with significant hands-on experience within the Medical Device, In-Vitro Diagnostics (IVD), and/or Combination Products industry.

The successful candidate will serve as a senior technical authority for supplier quality management, supplier auditing, regulatory compliance, CAPA/SCAPA,



supplier qualification, Quality Management Systems (QMS), and contract manufacturer oversight.

The role will be responsible for planning and conducting risk-based supplier audits of external suppliers, Contract Manufacturing Organizations (CMOs), critical component manufacturers, sterilization providers, laboratories, and other critical service providers.

The SME will ensure suppliers operate in compliance with applicable requirements, including ISO 13485, FDA Quality System requirements, EU MDR/IVDR, and other applicable global regulations and standards, while protecting product quality, patient safety, and supply continuity.

Key Responsibilities

Supplier Quality Auditing

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Plan, lead, execute, and document risk-based supplier audits across global supplier networks.

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Conduct onsite, remote, qualification, surveillance, for-cause, and requalification audits.

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Audit organizations includi

📌 Supplier Quality Auditor Subject Matter Expert (Bengaluru)
🏢 NTT DATA Services
📍 Bengaluru