Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

This is a fully remote position, open to applicants in Alabama, +10 more states.

📋 Description

• Design, manage, and consistently enhance a global Quality Management Program for third-party logistics (3PL).

• Create qualification frameworks, quality agreements, and re-evaluation controls for logistics and 3PL vendors.

• Standardize quality controls, distribution supervision, and logistics quality benchmarks across global regional entities.

• Supervise the operational execution of 3PL, including storage validation, environmental monitoring, product handling, serialized inventory, labeling/repackaging, and transportation controls.

• Conduct risk-based audits of global 3PL providers, distribution centers, and service suppliers.

• Develop audit schedules, risk models, protocols, checklists, and reporting formats.

• Execute audits in compliance with GDP, ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 standards.

• Assess findings, produce audit reports, drive root-cause analysis, and manage SCAR/CAPA reviews and effectiveness validations.

• Lead strategic quality engineering initiatives and continuous process improvement projects.

• Enhance Quality Management System platforms including Trackwise, SAP, and Agile.

• Establish and evaluate quality metrics, trends, and KPIs.

• Manage process nonconformances and CAPAs associated with 3PL, logistics, and supply-chain audits.

• Oversee 3PL SCARs from initiation to resolution.

• Support governance of the Approved Supplier List.

• Maintain supplier documentation, audit files, certifications, quality agreements, and ARFs.

• Act as a subject matter expert during FDA inspections, Notified Body audits, and internal QMS audits.

• Determine methods and procedures for intricate assignments with limited supervision.

• Mentor, coach, and guide junior compliance and supplier quality engineering personnel.

⛳️ Requirements

• Certification as an ISO 13485 Lead Auditor with proven experience conducting multi-site external audits globally.

• In-depth knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and Good Distribution Practice (GDP/GMP) standards.

• Experience overseeing quality and conducting audits of global 3PLs, cold-chain storage, distribution networks, and service suppliers.

• Advanced proficiency with Trackwise, SAP, and Agile.

• Strong grasp of ISO 14971 risk management principles.

• A BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related technical field is preferred.

• At least 12 years of relevant 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 organization is required.

• Direct experience in auditing and managing global 3PL providers, temperature-controlled distribution, and supply chain logistics in a regulated medical device setting is preferred.

• Familiarity with auditing service suppliers and distributors in a regulated medical device context is preferred.

• Candidates may be subject to U.S. export-control regulations.

• Preference will be given to qualified applicants who do not live in, or intend to live in, Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

🏝️ Benefits

• Opportunity for remote work; employees are required to come onsite only when requested by their leader.

• Compensation package includes base salary, incentives, benefits, and equity options.

• Possible vaccination coverage requirement for certain diseases, including COVID-19.

• Reasonable accommodations provided during the application or interview processes.

• Equal employment opportunity and protections against discrimination.