Job Information
Philips Global Supplier Senior Quality Lead Auditor in Orange, Ohio
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.
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.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Learn more about our culture. (https://www.careers.philips.com/na/en/our-culture-philips-careers)
Philips Transparency Details
The pay range for this position in Colorado Springs, CO, Latham, NY, Murrysville, PA, Nashville, TN, Orange Village, OH, and Reedsville, PA is $117,000 to $186,000.
The pay range for this position in Malvern, PA, and Plymouth, MN is $123,000 to $195,000.
The pay range for this position in Bothell, WA, Cambridge, MA, and San Diego, CA is $131,000 to $208,000.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here (https://www.philipsusbenefits.com/) .
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations .
#LI-PH1
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran