About this role
Role Overview
- 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