Global 3PL Quality Lead Auditor, ISO 13485

Intuitive; Georgia; Remote; USD 120,000 - 190,000; Full time

Job summary

Intuitive seeks a Staff Supplier Quality Engineer to lead worldwide 3PL quality management, audits, and supplier qualification within a complex global supply chain.

You will develop qualification frameworks, drive risk-based audits, and ensure conformance to 21 CFR Part 820, ISO 13485, EU MDR, GDP, and related requirements. This role interfaces with operations, RA/QA, and logistics across regions.

Qualifications

• Lead Auditor with ISO 13485 experience across sites.
• Expert knowledge of 21 CFR Part 820, ISO 13485, EU MDR and GDP.
• Proven audits of global 3PLs, distribution networks and service suppliers.
• Proficiency with Trackwise, SAP and Agile for supplier management.
• Strong ISO 14971-based risk management in logistics.

Responsibilities

• Lead and execute global 3PL audits and supplier qualifications.
• Design audit master schedules, risk models, and reporting templates.
• Ensure GDP, ISO 13485, and other standards across regions.
• Manage SCAR/CAPA processes and track corrective actions.
• Mentor junior staff and collaborate with cross-functional teams.

Skills

Lead Auditor (ISO 13485)

3PL quality oversight

Regulatory audits

Cross-functional collaboration

Risk management

Education

BS/BA in Engineering, Life Sciences, or related field

12+ years in related field; 8+ years with Master's; or PhD with experience

Experience in GxP-regulated medical device environment

Tools

Trackwise

SAP

Agile

Job description

Intuitive seeks a Staff Supplier Quality Engineer to lead worldwide 3PL quality management, audits, and supplier qualification within a complex global supply chain.

You will develop qualification frameworks, drive risk-based audits, and ensure conformance to 21 CFR Part 820, ISO 13485, EU MDR, GDP, and related requirements. This role interfaces with operations, RA/QA, and logistics across regions.