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

Intuitive•Peachtree Corners, GA

1d•$155,500 - $263,100•Remote

About The Position

The Staff Supplier Quality Engineer operates independently to establish methodologies, audit frameworks, quality systems, and procedural controls across the global supply chain, reporting to the Director, Global Supply Chain Audits. The 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 worldwide. It leads risk-based audit programs, ensures compliance with applicable regulatory standards, and serves as a subject matter expert during regulatory inspections. The position partners with global operations, logistics, and regional RAQA teams to improve processes, resolve systemic quality issues, ensure CAPA effectiveness, and advance 3PL compliance maturity. The role designs and improves a worldwide 3PL Quality Management Program covering logistics providers, distribution hubs, forward stocking locations, temperature-controlled facilities, and fulfillment partners. It establishes qualification frameworks and quality agreements; oversees 3PL operations and controls; leads supplier and service-provider audits; and manages audit findings, SCARs, CAPAs, supplier records, and quality metrics. It also leads strategic quality projects, supports QMS software improvements, and mentors junior staff. The position is remote in the United States and requires 50% international travel. The listed shift is day shift. Compensation ranges depend on region: $155,500–$223,600 for Region 2 and $182,900–$263,100 for Region 1. The employer notes that the position may be filled at a different job level depending on business need and the selected candidate’s qualifications.

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 principles 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.
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.
Experience auditing service suppliers and distributors in a regulated medical-device environment.
A BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline is preferred.

Responsibilities

Design, own, and continuously improve a global 3PL Quality Management Program covering logistics providers, distribution hubs, forward stocking locations, cold-chain facilities, and fulfillment partners.
Establish and maintain 3PL qualification frameworks, quality agreements, and re-evaluation controls aligned with applicable regulatory and distribution requirements.
Harmonize 3PL quality controls, distribution oversight, and logistics quality standards across regional entities.
Oversee 3PL operations, including storage validation, environmental monitoring, product handling, serialized inventory controls, localized labeling and repackaging, and transportation controls.
Lead and execute risk-based audits of worldwide 3PL providers, distribution hubs, and service suppliers, including sterilization, calibration, test laboratories, and software/IT GxP vendors.
Design and maintain 3PL audit schedules, risk models, protocols, checklists, and reporting templates.
Evaluate audit findings, issue audit reports, drive root-cause analysis, and manage SCAR/CAPA phase-gate reviews and effectiveness verification.
Lead strategic quality engineering projects and process-improvement initiatives for supply-chain workflows, 3PL 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 for 3PL performance, supplier corrective actions, and audit-program effectiveness.
Own process nonconformances and CAPAs related to 3PL, logistics, and supply-chain audit processes, ensuring rigorous root-cause analysis and sustainable corrective actions.
Manage 3PL SCARs 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.
Administer 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 on 3PL controls, GDP compliance, service-supplier qualification, and supply-chain audits.
Determine methods and procedures independently for new, complex, or special assignments with minimal supervision.
Mentor, coach, and guide junior compliance and supplier quality engineering staff; may supervise or mentor their activities.