Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

Intuitive

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

Posted 11/2/2026full-timeRemote • United StatesSenior💰 $155,500 - $263,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance, particularly in the context of 3PL and logistics within the medical device industry. Proficient in leading audits, managing supplier quality, and implementing continuous improvement initiatives.

Highest-signal resume keywords

ISO 13485 Lead Auditor CertificationExpert Knowledge of 21 CFR Part 820Experience Leading Quality Oversight of Global 3PLsProficiency with Trackwise, SAP, and AgileSignificant Experience in GxP-Regulated Environments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management Systems (QMS)Risk Management PrinciplesAudit Scheduling and ReportingRoot-Cause AnalysisCAPA ManagementQuality Metrics AnalysisEnvironmental MonitoringProduct Handling ControlsTemperature-Controlled DistributionSerialized Inventory Management

Soft Skills

Mentoring and CoachingLeadershipCommunicationProblem-SolvingCollaboration

Tools & Technologies

TrackwiseSAPAgile

Certifications & Qualifications

ISO 13485 Lead Auditor Certification

Industry Keywords

Good Distribution Practice (GDP)ISO 13485:2016EU MDR 2017/745GxP-Regulated EnvironmentMedical Device Industry3PL Quality ManagementSupply Chain ManagementCold-Chain StorageService Supplier AuditingFDA Inspections

About the role

Key responsibilities & impact

Design, own, and continuously improve a global 3PL Quality Management Program
Establish 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
Oversee 3PL operational execution, including 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
Develop 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
Improve QMS platforms including Trackwise, SAP, and Agile
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 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 with minimal supervision
Mentor, coach, and guide junior compliance and supplier quality engineering staff

Requirements

What you’ll need

ISO 13485 Lead Auditor certification/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 Good Distribution Practice (GDP/GMP) requirements
Experience leading quality oversight and audits of 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 a related technical discipline preferred
Minimum 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or a PhD with 5 years of experience; or equivalent demonstrated experience
Significant experience in a high-volume, globally distributed medical device or GxP-regulated company required
Direct experience auditing and managing worldwide 3PL providers, temperature-controlled distribution, and global supply chain logistics in a regulated medical device environment preferred
Exposure to auditing service suppliers and distributors in a regulated medical device environment preferred
Candidates may be subject to U.S. export-control requirements
Preference given to qualified applicants who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee

Benefits

Comp & perks

Remote work; employees come onsite when requested by the leader
Base pay, incentives, benefits, and equity
Potential vaccination coverage requirement for certain diseases, including COVID-19
Reasonable accommodations during the application or interview process
Equal employment opportunity and anti-discrimination protections