Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA
About The 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. The role reports to the Director, Global Supply Chain Audits. The position is responsible for 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. It leads risk-based audits and ensures conformance to applicable global requirements, including 21 CFR Part 820, ISO 13485, EU MDR 2017/745, and Good Distribution Practice (GDP). The role serves as a subject matter expert during regulatory inspections and partners with global operations, logistics, and regional RAQA organizations to improve processes, resolve systemic quality issues, ensure CAPA effectiveness, and advance 3PL supply chain compliance maturity.
Requirements
- ISO 13485 Lead Auditor qualification and 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.
- Typically, at least 12 years of related experience with a bachelor's degree; or 8 years with a master's degree; or 5 years with a PhD; or equivalent demonstrated experience.
- Significant experience in a high-volume, globally distributed medical device or GxP-regulated company.
- A bachelor's degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline is preferred.
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 the global 3PL Quality Management Program for 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 GDP requirements.
- Harmonize 3PL quality controls, distribution oversight, and logistics quality standards across regional entities.
- Maintain quality oversight of 3PL operations, 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 requirements.
- Evaluate audit findings, issue formal reports, drive root cause analysis, and manage SCAR/CAPA phase-gate reviews and effectiveness verifications.
- Lead strategic quality engineering and continuous improvement projects to optimize 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; ensure rigorous root cause analysis and sustainable corrective actions.
- Manage 3PL SCARs from issuance through aging tracking, phase-gate reviews, effectiveness verification, and closure.
- Support Approved Supplier List governance for 3PL status, including promotions, conditional approvals, and demotions.
- Administer and 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 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.
Benefits
- Market-competitive compensation packages including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
