About this role
Job Title Global Supplier Quality Lead Auditor (all genders) Job Description 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. The role can be based in our Best, Amsterdam or Drachten office. 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.
Compensation & benefits for Boblingen office Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is € 103,510.62 –€ 138,014.16. 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 5% bonus, with your rewards linked to your performance and company performance. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Philips benefits for you:
• Annual leave: 30 days
• Mobility and devices: subsidized Germany ticket, leasing opportunities for private use (bicycles, cars, smartphones,…)
• Philips University & Philips in Balance: Wide range of professional training courses and for personal development & Healthcare
• Philips Pension Fund: Employer-funded pension plan
• “Partnerzeit” – two paid weeks off after your partner has given birth
• Philips MyShop: Discount on Philips products
• Free drinks and low prices in our canteen and Café
• Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.
How we work together We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.
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. #LI-EU