Global Supplier Senior Quality Lead Auditor

Philips • Nashville, TN

1d • $117,000 - $208,000 • Onsite

About The Position

The Global Supplier Senior Quality Lead Auditor will conduct external supplier audits for medical device components, products, and services. This role is critical in ensuring that our supply base maintains robust, compliant, and effective Quality Management Systems (QMS) aligned with ISO 13485, ISO 9001, and/or applicable regulatory requirements. The Lead Auditor will evaluate supplier processes, identify risks, drive corrective action, and support qualification and requalification activities essential to patient safety and regulatory compliance.

Requirements

• 10+ years of experience with bachelor’s OR minimum 7+ years of experience with master’s in areas such as Quality Engineering, Safety Engineering, Process Engineering, Continuous Improvement Techniques or equivalent.
• Demonstrated experience conducting external supplier’s audits in the medical device industry required.
• Formal training in ISO 13485 and Iso 9001 (minimum); additional standards such as ISO 17025 are preferred.
• Must have proficiency with audit management systems and documentation tools.
• Bachelor’s degree in engineering science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent required, master’s degree preferred.
• Certified Lead Auditor through a recognized program (IRCA, RAB-QSA, ASQ, BSI, TUV) or completion of an approved internal Lead Auditor training program required.
• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• Strong attention to detail, analytical thinking, and sound professional judgment; and a proven ability to work independently to manage multiple audits in parallel.
• Must be willing and able to travel up to 50% domestically and internationally to supplier sites and flexible to work across time zones as needed.

Nice To Haves

• Strong understanding of medical device QMS, supplier controls, and regulatory expectations
• Ability to assess complex manufacturing and quality processes and identify risk-based improvement opportunities
• Excellent communication, negotiation, and relationship building skills with external partners

Responsibilities

• Audit Planning & Preparation: Develop audit plans and agendas for external suppliers based on risk, supplier classification, and regulatory requirements, ensuring all documentation is ready before audits.
• Execution of Supplier Audits: Lead remote and on-site audits of supplier Quality Management Systems, assessing compliance with standards like ISO 13485 and ISO 9001, and evaluating manufacturing controls, process validation, and risk management.
• Audit Reporting & Follow-Up: Prepare comprehensive audit reports detailing findings and recommendations, communicate outcomes to suppliers and internal stakeholders, and manage corrective action plans to resolve nonconformities.
• Compliance & Professional Development: Maintain current knowledge of regulatory expectations and QMS standard revisions, completing necessary training and requalification activities when standards change.
• Continuous Improvement: Serve as a subject matter expert for supplier audit practices, contributing to ongoing improvements within the audit program.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees