Global Supplier Senior Quality Lead Auditor

Job Title

Global Supplier Senior Quality Lead Auditor

Job Description

580144 Global Supplier Senior Quality Lead Auditor

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.

Your role

• 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.

You're the right fit if

• You’ve acquired 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.
• Your skills include 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. Preferred skills include 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; and excellent communication, negotiation, and relationship building skills with external partners.
• You have a 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.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• You have 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.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

Compensation & benefits

Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is EUR 78187.00 - EUR 130,312.00 gross per year. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.

This role is eligible for 3% short term incentive with your rewards linked to both individual performance and company results. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include hybrid working, paid time-off, health and wellbeing benefits, learning and development opportunities.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business .
• Discover our rich and exciting history .
• Learn more about our purpose .

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .

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