Senior Quality Lead Auditor, Global Supplier
Philips
full-time
Posted on:
Location Type: Office
Location: Nashville • Colorado • Pennsylvania • United States
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Salary
💰 $117,000 - $208,000 per year
Job Level
About the role
- conduct external supplier audits for medical device components, products, and services
- develop audit plans and agendas for external suppliers based on risk, supplier classification, and regulatory requirements
- lead remote and on-site audits of supplier Quality Management Systems, assessing compliance with standards like ISO 13485 and ISO 9001
- prepare comprehensive audit reports detailing findings and recommendations
- maintain current knowledge of regulatory expectations and QMS standard revisions
- serve as a subject matter expert for supplier audit practices
Requirements
- 10+ years of experience with bachelor’s OR minimum 7+ years of experience with master’s
- demonstrated experience conducting external supplier’s audits in the medical device industry required
- formal training in ISO 13485 and ISO 9001 (minimum); additional standards such as ISO 17025 are preferred
- proficiency with audit management systems and documentation tools
- 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
Benefits
- 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
supplier auditsQuality Management SystemsISO 13485ISO 9001ISO 17025audit management systemsdocumentation toolsrisk assessmentregulatory complianceaudit reporting
Soft Skills
leadershipcommunicationorganizational skillssubject matter expertiseanalytical skillsattention to detailproblem-solvingteam collaborationtime managementadaptability
Certifications
Certified Lead AuditorIRCARAB-QSAASQBSITUVinternal Lead Auditor training