Supplier Quality Auditor Subject Matter Expert (SME) - Medical Devices

Supplier Quality Auditor Subject Matter Expert (SME) - Medical Devices

Req ID: 391809 

NTT DATA strives to hire exceptional, innovative 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

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

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

• Audit organizations including:

  • Contract manufacturers

  • Critical component/material suppliers

  • Sterilization facilities

  • Testing laboratories

  • Packaging suppliers

  • Critical service providers

• Develop audit plans, agendas, checklists, reports, findings, and follow-up actions.

• Evaluate supplier manufacturing and quality processes using process- and evidence-based auditing techniques.

• Ensure audit observations and findings are appropriately classified, documented, communicated, and resolved.

Regulatory & Quality Compliance

• Assess supplier compliance with applicable regulations and standards, including:

  • ISO 13485 – Medical Device Quality Management Systems

  • Applicable FDA medical-device Quality System requirements

  • 21 CFR Parts 210/211, where applicable

  • EU MDR 2017/745

  • EU IVDR 2017/746

• Interpret regulatory and quality requirements and translate them into actionable supplier controls.

• Monitor regulatory and standards changes and assess their potential impact on supplier quality processes.

• Support continued audit and inspection readiness across the supplier network.

Supplier CAPA / SCAPA & Nonconformance Management

• Lead and oversee Supplier Corrective and Preventive Action (SCAPA) activities.

• Review supplier investigations, root-cause analyses, containment plans, corrective actions, and preventive actions.

• Evaluate CAPA adequacy and verify effectiveness of implemented corrective actions.

• Drive timely closure of supplier nonconformances and quality issues.

• Facilitate escalation of significant or recurring supplier quality problems.

• Partner with suppliers and internal stakeholders to prevent recurrence of quality issues.

Supplier Qualification & Risk Management

• Lead supplier pre-qualification, qualification, approval, and requalification activities.

• Assess supplier capabilities, manufacturing processes, technical controls, validation practices, and QMS maturity.

• Support risk-based supplier segmentation and determine appropriate oversight based on supplier/product criticality.

• Review supplier-related risk assessments, including Process FMEA (PFMEA) and other applicable risk-management documentation.

• Support new supplier selection and onboarding.

• Maintain and support governance of the Approved Supplier List (ASL).

Quality Agreements & Supplier Performance

• Develop, review, negotiate, and maintain Supplier Quality Agreements / Quality Technical Agreements (QTAs).

• Clearly define responsibilities related to:

  • Quality requirements

  • Change notification

  • Deviations and nonconformances

  • CAPA

  • Complaint investigations

  • Regulatory inspections

  • Documentation and record retention

• Establish and monitor supplier quality KPIs, scorecards, and performance metrics.

• Identify supplier quality trends and recommend corrective or preventive actions.

• Present supplier performance, risks, and quality trends to management and executive stakeholders.

QMS & Technical Quality Oversight

• Evaluate supplier Quality Management Systems and their integration with internal QMS requirements.

• Assess supplier controls related to:

  • Design controls

  • Manufacturing processes

  • Process validation

  • Equipment qualification

  • Change control

  • Document control

  • Nonconformance management

  • CAPA

  • Training

  • Traceability

  • Complaint handling

  • Sterilization

• Review technical protocols, validation reports, manufacturing records, and other quality documentation.

• Ensure supplier changes are appropriately evaluated for product, regulatory, and quality impact.

Regulatory Inspection Support

• Serve as a Supplier Quality SME during regulatory inspections and Notified Body audits.

• Support inspections involving FDA, Notified Bodies, and other global regulatory authorities.

• Provide documentation and technical explanations regarding supplier qualification, controls, monitoring, audits, and CAPA.

• Support responses to regulatory observations related to supplier quality.

• Ensure supplier quality documentation remains inspection-ready.

Cross-Functional Leadership

• Partner closely with Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, R&D, Procurement, Supply Chain, Operations, and Legal.

• Provide SME-level guidance on supplier quality and regulatory compliance matters.

• Influence suppliers and internal stakeholders to drive quality improvements and risk reduction.

• Lead complex supplier-quality investigations and remediation initiatives.

• Mentor Supplier Quality Engineers and auditors on audit methodologies and regulatory expectations.

• Conduct internal training on supplier quality processes, audit practices, and applicable regulations.

Required Qualifications

• 10+ years of progressive experience in Healthcare/Life Sciences, with significant experience in Medical Device, IVD, and/or Combination Product Quality.

• 7+ years of extensive hands-on experience in Supplier Quality Engineering, Supplier Quality Auditing, Quality Assurance, or Regulatory Compliance.

• 5+ years of demonstrated experience serving as a Lead Auditor for suppliers and contract manufacturers.

• Strong hands-on knowledge of ISO 13485 and applicable FDA medical-device Quality System requirements.

• Experience with EU MDR/IVDR requirements as they relate to supplier and outsourced-process controls.

• Strong experience with CAPA/SCAPA, root-cause analysis, nonconformance management, and effectiveness verification.

• Experience with supplier qualification, requalification, risk assessment, and Approved Supplier List management.

• Experience developing and managing Supplier Quality Agreements/QTAs.

• Strong understanding of QMS, design controls, process validation, risk management, PFMEA, and manufacturing quality systems.

• Demonstrated experience supporting FDA and/or Notified Body inspections.

• Strong audit-report writing and technical documentation skills.

• Excellent communication, negotiation, problem-solving, and stakeholder-management capabilities.

Education

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemistry, Life Sciences, or a related scientific/technical discipline.

• Advanced degree in Engineering, Quality, Regulatory Affairs, or a related discipline is preferred.

Preferred Certifications

• ASQ Certified Quality Auditor (CQA)

• ASQ Certified Quality Engineer (CQE)

• ISO 13485 Lead Auditor Certification

• Other recognized Medical Device Quality or Regulatory certifications

Preferred Experience

• Experience auditing high-risk medical-device or IVD suppliers.

• Experience auditing Contract Manufacturing Organizations (CMOs) and critical component manufacturers.

• Experience with sterilization, packaging, electronics, software, or other critical outsourced processes.

• Experience managing global suppliers across multiple geographic regions.

• Experience working in large multinational Medical Device/Healthcare/Life Sciences organizations.

• Demonstrated ability to independently lead complex supplier audits and remediation activities.

Key Skills

Supplier Quality Auditing | Supplier Quality Engineering | Medical Devices | ISO 13485 | FDA Quality System Requirements | EU MDR | EU IVDR | CAPA | SCAPA | Root Cause Analysis | QMS | Supplier Qualification | Supplier Risk Management | Quality Agreements | QTA | Approved Supplier List | PFMEA | Process Validation | Design Controls | Contract Manufacturing | Regulatory Inspections | CQA | CQE | Life Sciences

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.

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Experience Level

Senior Level