Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA

Peachtree Corners, GA, United States Remote Available Quality & Regulatory JOB219840 Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Job Description Primary Function of Position 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, reporting to the Director, Global Supply Chain Audits. 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. The Staff SQE leads risk-based lead audit programs, ensures conformance to applicable global regulatory standards (21 CFR Part 820, ISO 13485, EU MDR 2017/745, Good Distribution Practice / GDP), and serves as a subject matter expert (SME) in regulatory body inspections. S/he partners with cross-functional global operations, logistics, and regional RAQA organizations to drive critical process improvement projects, resolve systemic quality issues, ensure CAPA effectiveness, and advance 3PL supply chain compliance maturity. Essential Job Duties 3PL Quality Management & Worldwide Oversight 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 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 Audits & Supplier / Service Qualification 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). Design, own, and update 3PL audit master schedules, audit risk models, protocols, checklists, and reporting templates tailored to third-party logistics and service supplier activities. Conduct Lead Audits against applicable global regulatory standards including Good Distribution Practice (GDP), ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 subpart requirements. Evaluate audit findings, issue formal audit reports, drive root cause analysis rig…

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