Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

Intuitive

. Design, own, and continuously improve a global 3PL Quality Management Program .

Posted 11/4/2026full-timeRemote • Peachtree Corners • Georgia • United StatesSenior💰 $155,500 - $263,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Programs for global 3PL operations, with a strong focus on compliance with ISO standards and regulatory requirements. Proven ability to lead audits, manage quality metrics, and drive continuous improvement initiatives in logistics and supply chain environments.

Highest-signal resume keywords

ISO 13485 Lead Auditor ExperienceExpert Knowledge of 21 CFR Part 820Proficiency with Trackwise, SAP, and AgileExperience in Auditing Global 3PLsStrong Understanding of ISO 14971 Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management Program DesignAudit Schedule CreationRoot-Cause AnalysisCAPA ManagementQuality Metrics AnalysisRisk-Based AuditingProcess ImprovementRegulatory ComplianceCold-Chain Storage OversightLogistics Quality Standards

Soft Skills

MentoringCoachingLeadershipCommunicationCollaboration

Tools & Technologies

TrackwiseSAPAgile

Certifications & Qualifications

ISO 13485 CertificationLead Auditor Certification

Industry Keywords

3PLGxPGood Distribution PracticeMedical DeviceEU MDR 2017/745

About the role

Key responsibilities & impact

Design, own, and continuously improve a global 3PL Quality Management Program
Establish and maintain qualification frameworks, quality agreements, and re-evaluation controls for 3PL and logistics vendors
Harmonize 3PL quality controls, distribution oversight, and logistics quality standards across global regional entities
Maintain quality oversight of storage validation, environmental monitoring, product handling, serialized inventory, labeling/repackaging, and transportation controls
Lead risk-based audits of worldwide 3PL providers, distribution hubs, and service suppliers
Create and maintain audit schedules, risk models, protocols, checklists, and reporting templates
Conduct audits against GDP, ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 requirements
Evaluate findings, issue audit reports, drive root-cause analysis, and manage SCAR/CAPA reviews and effectiveness verification
Lead strategic quality engineering and continuous process-improvement projects
Partner with IT and Supply Chain teams to improve Trackwise, SAP, and Agile workflows
Establish and analyze quality metrics, trends, and KPIs
Own process nonconformances and CAPAs related to 3PL, logistics, and supply-chain audits
Manage 3PL SCARs from issuance through closure
Support Approved Supplier List governance
Maintain 3PL and service-supplier records, audit files, certifications, quality agreements, and ARFs
Serve as subject-matter expert during FDA inspections, Notified Body audits, and internal QMS audits
Determine methods and procedures for complex assignments independently
Mentor, coach, and guide junior compliance and supplier quality engineering staff

Requirements

What you’ll need

ISO 13485 Lead Auditor experience 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 Good Distribution Practice (GDP/GMP) requirements
Proven experience overseeing and auditing global 3PLs, cold-chain storage, distribution networks, and service suppliers
Expert proficiency with Trackwise, SAP, and Agile
Strong understanding of ISO 14971 risk management principles
BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or related technical discipline preferred
Minimum 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or PhD with 5 years of experience; or equivalent demonstrated experience
Significant experience in a high-volume, globally distributed medical device or GxP-regulated company
Willingness to travel 50% internationally
Current proof of vaccination against certain diseases, including COVID-19, may be required
Candidates may be subject to U.S. export-control licensing or a Technology Control Plan
Qualified applicants must meet applicable U.S. work authorization/export-control requirements where applicable

Benefits

Comp & perks

Remote work arrangement; employees come onsite when requested by the leader
Incentives
Benefits
Equity
Potential vaccination coverage requirement/support depending on role
Reasonable accommodations during the application or interview process