Global Supplier Quality Lead Auditor
Philips
full-time
Posted on:
Location Type: Hybrid
Location: Nashville • Colorado • Pennsylvania • United States
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Salary
💰 $94,000 - $150,000 per year
Job Level
About the role
- Conduct external supplier audits for medical device components, products, and services
- Develop tailored audit plans and agendas for external suppliers
- Lead remote and on-site audits of suppliers' Quality Management Systems
- Apply risk-based auditing principles to examine interdependencies across QMS processes
- Prepare clear audit reports detailing findings and recommendations
- Stay current on regulatory expectations and QMS standards
Requirements
- 7+ years of experience
- Bachelor's in Quality Engineering, Safety Engineering, Process Engineering, or equivalent
- Demonstrated experience conducting external supplier audits in the medical device industry
- Formal training in ISO 13485 and ISO 9001; additional standards such as ISO 17025 are preferred
- Proficiency with audit management systems and documentation tools
- 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
- Certified Lead Auditor through a recognized program (IRCA, RAB-QSA, ASQ, BSI, TUV) or completion of an approved internal Lead Auditor training program
Benefits
- Comprehensive Philips Total Rewards benefits program
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
external supplier auditsaudit management systemsrisk-based auditingQuality Management Systems (QMS)ISO 13485ISO 9001ISO 17025manufacturing processesquality processesregulatory compliance
Soft Skills
communication skillsnegotiation skillsrelationship-building skillsanalytical skillsproblem-solving skills
Certifications
Certified Lead AuditorIRCARAB-QSAASQBSITUV