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

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 rigor with 3PL leadership, and manage SCAR / CAPA phase gate reviews and effectiveness verifications.

· Projects & Process Improvements

· Lead strategic quality engineering projects and continuous process improvement initiatives to optimize supply chain workflows, streamline 3PL quality oversight, and elevate supplier scorecards.

· Partner with IT and Supply Chain teams to drive continuous improvement of QMS software platforms (Trackwise, SAP, Agile) supporting 3PL quality workflows, audit scheduling, and SCAR tracking.

· Establish and analyze quality metrics, trends, and KPIs regarding 3PL performance, supplier corrective actions, and audit program effectiveness.

· Own Process Nonconformances (NCs) and CAPAs related to 3PL, logistics, and supply chain audit processes, ensuring root cause rigor (6M / 5-Why) and sustainable corrective actions.

· Supplier Controls & QMS Administration

· Manage 3PL Supplier Corrective Action Requests (SCARs) end-to-end: issuance, aging tracking, phase gate reviews, effectiveness verification, and closure.

· Support Approved Supplier List (ASL) governance regarding 3PL status maintenance, including promotions, conditional approvals, and demotions.

· Administer and maintain 3PL and service supplier records in Trackwise, SAP, and Agile, including audit files, ISO/GDP certifications, quality agreements, and ARFs.

· Regulatory Audit Support & Leadership

· Serve as SME during FDA inspections, Notified Body audits (e.g., BSI, TÜV), and internal QMS audits for all matters related to 3PL Controls, GDP compliance, Service Supplier qualification, and Supply Chain Audits.

· Operate independently to determine methods and procedures on new, complex, or special assignments with minimal supervision.

· Mentor, coach, and guide junior compliance and supplier quality engineering staff.

· May supervise or mentor the activities of junior compliance and supplier quality staff.

Qualifications

Required Skills and Experience

• ISO 13485 Lead Auditor with demonstrated experience leading multi-site external audits worldwide.

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