Global Supplier Quality Lead Auditor
PhilipsAbout the role
Job Title
Global Supplier Quality Lead AuditorJob Description
Global Supplier Quality Lead Auditor
The Global Supplier 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:
- Develop tailored audit plans and agendas for external suppliers by considering their classification, risk level, and regulatory requirements, ensuring all documentation is prepared in advance.
- Lead remote and on-site audits of suppliers' Quality Management Systems, evaluating compliance with ISO standards and assessing critical processes such as manufacturing controls, risk management, and CAPA.
- Apply risk-based auditing principles to examine interdependencies across QMS processes and accurately determine audit scope using supplier performance data and quality history.
- Prepare clear audit reports detailing findings and recommendations, communicate outcomes to suppliers and internal teams, and manage corrective action plans to resolve nonconformities.
- Stay current on regulatory expectations and QMS standards, complete necessary training and requalification, and serve as a subject matter expert to drive continuous improvement in audit practices.
You're the right fit if:
- You’ve acquired 7+ years of experience with bachelor’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.
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 improve the lives of others.