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

Intuitive•Peachtree Corners, GA

3d•Remote

About The Position

The Staff Supplier Quality Engineer operates independently to determine methodologies, audit frameworks, quality systems, and procedural controls across Intuitive’s global supply chain. Reporting to the Director, Global Supply Chain Audits, this role leads 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 role owns a global 3PL Quality Management Program covering logistics providers, distribution hubs, forward stocking locations, temperature-controlled storage facilities, and fulfillment partners. It establishes qualification frameworks, quality agreements, and reevaluation controls, and oversees quality aspects of storage, product handling, inventory controls, labeling, and transportation. The position leads risk-based audits and supplier qualification activities, manages audit findings and SCAR/CAPA processes, and drives quality metrics and process improvements. The Staff Supplier Quality Engineer supports regulatory inspections and internal audits as a subject matter expert on 3PL controls, Good Distribution Practice (GDP), service supplier qualification, and supply chain audits. The role collaborates with global operations, logistics, IT, Supply Chain, and regional RAQA teams, and may mentor or guide junior compliance and supplier quality staff. The position is remote from the USA and requires 50% international travel.

Requirements

ISO 13485 Lead Auditor qualification 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 GDP/GMP requirements applicable to 3PL, logistics, and service supplier controls.
Proven experience leading quality oversight and audits of global 3PLs, cold-chain storage, distribution networks, and service suppliers.
Expert proficiency with Trackwise, SAP, and Agile for supplier file management, SCAR tracking, and audit scheduling.
Strong understanding of ISO 14971 risk management as applied to 3PL risk stratification, logistics risk assessments, and audit frequency determination.
Significant experience in a high-volume, globally distributed medical device or GxP-regulated company.
Typically, at least 12 years of related experience with a bachelor’s degree, 8 years with a master’s degree, or 5 years with a PhD; equivalent demonstrated experience is also accepted.
Bachelor’s degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline is preferred.
Ability to travel internationally 50%.

Nice To Haves

Direct experience auditing and managing worldwide 3PL providers, temperature-controlled distribution, and global supply chain logistics in a regulated medical device environment.
Exposure to auditing service suppliers and distributors in a regulated medical device environment.

Responsibilities

Design, own, and continuously improve a global 3PL Quality Management Program covering logistics providers, distribution hubs, forward stocking locations, temperature-controlled storage facilities, and fulfillment partners.
Establish and maintain 3PL qualification frameworks, quality agreements, and reevaluation controls aligned with applicable regulatory and GDP requirements.
Harmonize 3PL quality controls, distribution oversight, and logistics quality standards across regional entities.
Oversee 3PL operational quality, including storage validation, environmental monitoring, product handling, serialized inventory controls, localized labeling or repackaging, and transportation controls.
Lead risk-based audits of worldwide 3PL providers, distribution hubs, and service suppliers, including sterilization, calibration, test laboratory, and software/IT GxP vendors.
Develop and maintain 3PL audit schedules, risk models, protocols, checklists, and reporting templates.
Conduct lead audits against applicable GDP, ISO, and FDA regulatory requirements.
Evaluate audit findings, issue formal audit reports, drive root cause analysis with supplier leadership, and manage SCAR/CAPA reviews and effectiveness verification.
Lead strategic quality engineering projects and process improvements to optimize supply chain workflows, quality oversight, and supplier scorecards.
Partner with IT and Supply Chain teams to improve QMS software platforms supporting 3PL quality workflows, audit scheduling, and SCAR tracking.
Establish and analyze quality metrics, trends, and KPIs related to 3PL performance, corrective actions, and audit program effectiveness.
Own process nonconformances and CAPAs related to 3PL, logistics, and supply chain audits, ensuring rigorous root cause analysis and sustainable corrective actions.
Manage 3PL Supplier Corrective Action Requests end-to-end, including issuance, aging tracking, phase gate reviews, effectiveness verification, and closure.
Support Approved Supplier List governance for 3PL status maintenance, including promotions, conditional approvals, and demotions.
Maintain 3PL and service supplier records in Trackwise, SAP, and Agile, including audit files, certifications, quality agreements, and ARFs.
Serve as a subject matter expert during FDA inspections, Notified Body audits, and internal QMS audits concerning 3PL controls, GDP compliance, service supplier qualification, and supply chain audits.
Determine methods and procedures independently for complex or special assignments with minimal supervision.
Mentor, coach, and guide junior compliance and supplier quality engineering staff; may supervise or mentor their activities.