Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

This is a fully remote position, open to applicants in Georgia.

📋 Description

• Design, manage, and continuously enhance a global Third-Party Logistics (3PL) Quality Management Program.

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

• Standardize 3PL quality controls, distribution oversight, and logistics quality standards across global regional units.

• Maintain quality oversight concerning storage validation, environmental monitoring, product handling, serialized inventory, labeling/repackaging, and transportation controls.

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

• Create and sustain audit schedules, risk models, protocols, checklists, and reporting templates.

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

• Analyze audit findings, generate reports, lead root-cause investigations, and manage SCAR/CAPA reviews and effectiveness verification.

• Spearhead strategic quality engineering and continuous process improvement initiatives.

• Collaborate with IT and Supply Chain teams to enhance Trackwise, SAP, and Agile workflows.

• Establish and assess quality metrics, trends, and key performance indicators (KPIs).

• Take ownership of process nonconformities and CAPAs related to 3PL, logistics, and supply chain audits.

• Oversee 3PL SCARs from inception to resolution.

• Support governance of the Approved Supplier List.

• Maintain records for 3PL and service suppliers, including audit files, certifications, quality agreements, and ARFs.

• Act as a subject-matter expert during FDA inspections, Notified Body audits, and internal Quality Management System (QMS) audits.

• Determine methods and procedures for complex assignments autonomously.

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

⛳️ Requirements

• Experience as an ISO 13485 Lead Auditor with proven capability in leading multi-site external audits globally.

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

• Demonstrated experience in overseeing and auditing global 3PLs, cold-chain storage, distribution networks, and service providers.

• Advanced proficiency in Trackwise, SAP, and Agile.

• Solid understanding of ISO 14971 risk management principles.

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

• A minimum of 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.

• Extensive experience in a high-volume, globally distributed medical device or GxP-regulated organization.

• Willingness to travel internationally up to 50% of the time.

• 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 fulfill applicable U.S. work authorization/export-control requirements where necessary.

🏝️ Benefits

• Flexible remote work arrangement; employees are required to come onsite upon request from leadership.

• Incentives.

• Comprehensive benefits package.

• Equity options.

• Potential requirement/support for vaccination coverage depending on the role.

• Reasonable accommodations available during the application or interview process.