Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA (50% Travel Internationally)

📋 Description

• Design, own, and continuously improve a global 3PL Quality Management Program encompassing
• Establish and maintain qualification frameworks, quality agreements (QAs), and re-evaluation
• Drive global harmonization of 3PL quality controls, distribution oversight, and logistics quality
• Maintain quality oversight of 3PL operational execution, including ambient/cold-chain storage
• Lead and execute comprehensive risk-based audits as Lead Auditor for worldwide 3PL providers
• Design, own, and update 3PL audit master schedules, audit risk models, protocols, checklists, and

🎯 Requirements

• ISO 13485 Lead Auditor with demonstrated experience leading multi-site external audits worldwide.
• Expert-level knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and Good Distribution
• Proven experience leading quality oversight and audits of global 3PLs, cold chain storage
• Expert proficiency with QMS platforms including Trackwise, SAP, and Agile for supplier file
• Strong understanding of risk management principles (ISO 14971) as applied to 3PL risk
• Education: BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related