Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA (50% Travel Internationally)
Intuitive · Posted Nov 4, 2026
- Remote, United States
- Remote
- Full-time · Staff
- 12+ years
The Staff Supplier Quality Engineer operates with a high degree of independence to determine methodologies, audit frameworks, quality systems, and procedural controls across the global supply chain ecosystem. This role is responsible for the technical execution, continuous improvement, strategic projects, and global harmonization of Third-Party Logistics (3PL) quality management, distribution center controls, and service supplier qualification processes worldwide.
Responsibilities
- Design, own, and continuously improve a global 3PL Quality Management Program encompassing third-party logistics providers, global distribution hubs, forward stocking locations, cold chain/temperature-controlled storage facilities, and fulfillment partners across all global regions.
- Establish and maintain qualification frameworks, quality agreements (QAs), and re-evaluation controls specific to 3PL providers and logistics vendors supporting GxP-regulated distribution processes in alignment with 21 CFR Part 820, ISO 13485 (Clause 7.5.5), EU MDR, and Good Distribution Practice / GDP requirements.
- Drive global harmonization of 3PL quality controls, distribution oversight, and logistics quality-standards across regional entities: ISJ, ISK, IS India, IS Aubonne, ISE, ISB, and IST.
- Maintain quality oversight of 3PL operational execution, including ambient/cold-chain storage validation, environmental monitoring, product handling, serialized inventory controls, localized labeling/repackaging, and transportation controls.
- Lead and execute comprehensive risk-based audits as Lead Auditor for worldwide 3PL providers, distribution hubs, and service suppliers (sterilization, calibration, test laboratories, software/IT GxP service vendors).