Global Supplier Quality Lead Auditor

Job Title

Global Supplier Quality Lead Auditor

Job Description

We are seeking an experienced Lead Auditor to 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.

Audit Planning & Preparation

• Develop audit plans and agendas for external suppliers based on supplier classification, risk level, and regulatory requirements.
• Review supplier performance data, previous audit results, and quality history to determine audit scope.
• Ensure all required audit documentation is prepared prior to execution.

Execution of Supplier Audits

• Lead remote and on‑site audits of suppliers’ Quality Management Systems to evaluate compliance with standards such as (but not limited to) ISO 13485 and ISO 9001.
• Assess core supplier processes, including manufacturing controls, process validation, risk management, documentation practices, CAPA, and design transfer.
• Apply risk‑based auditing principles and evaluate interdependencies across QMS processes.

Audit Reporting & Follow‑Up

• Prepare clear and comprehensive audit reports outlining findings, evidence, and recommendations.
• Communicate audit outcomes to suppliers and internal stakeholders, including Supplier Quality and Procurement.
• Own supplier corrective action plans (SCARs, SQNs) to ensure timely and effective resolution of nonconformities.

Compliance & Professional Development

• Maintain up‑to‑date knowledge of evolving regulatory expectations and QMS standard revisions.
• Complete required training and requalification activities when standards are updated.
• Serve as a subject matter expert for supplier audit practices and contribute to continuous improvement within the audit program.

Required Qualifications

• Certified Lead Auditor through a recognized program (IRCA, RAB‑QSA, ASQ, BSI, TÜV) or completion of an approved internal Lead Auditor training program.
• Formal training in ISO 13485 and ISO 9001 (minimum); additional standards such as ISO 17025 are preferred.
• Demonstrated experience conducting external supplier audits in the medical device, pharmaceutical, or regulated manufacturing industry.
• Proficiency with audit management systems and documentation tools.

Desired Skills & Competencies

• 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.
• High attention to detail, analytical thinking, and sound professional judgment.
• Ability to work independently and manage multiple audits in parallel.

Travel Requirements

• Ability to travel 30–50% domestically and internationally to supplier sites.
• Flexibility to work across different time zones as needed.

Minimum required Education:
Bachelor's/ Master's Degree in Engineering Science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.

Minimum required Experience:

Minimum 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.

Preferred Education:

Master's degree in Engineering

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.
Indicate if this role is an office/field/onsite 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 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.