Global 3PL Quality Lead Auditor (ISO 13485)

Regulatory Jobs; Peachtree Corners (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Staff Supplier Quality Engineer to lead global 3PL quality oversight and audits, ensuring GDP, ISO 13485, and regulatory compliance across distribution networks. You will design qualification frameworks and drive continuous improvement in 3PL quality controls.

The role requires lead audit experience, cross-functional collaboration, and the ability to manage CAPA/SCAR processes with a focus on 3PL reliability and regulatory readiness.

Qualifications

• ISO 13485 Lead Auditor with multi-site external audits worldwide.
• Expert knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and GDP.
• Proven experience auditing global 3PLs, cold chain, distribution networks.
• Proficiency with Trackwise, SAP, Agile for supplier file management and audit scheduling.
• Risk management per ISO 14971 in a 3PL context.

Responsibilities

• Lead global 3PL quality program and audits across distribution networks.
• Develop qualification frameworks, quality agreements, and re-evaluation controls.
• Audit 3PLs and service suppliers against GDP, ISO 13485, and ISO 17025.
• Drive CAPA/SCAR processes and verify effectiveness.
• Improve QMS platforms (Trackwise, SAP, Agile) for quality workflows.
• Mentor junior supplier quality engineers.

Skills

Lead Auditor

3PL Quality

Audit Leadership

QMS Administration

Risk Management

Education

BS/BA in Engineering or Life Sciences

GxP-regulated industry experience

Tools

Trackwise

SAP

Agile

Job description

Intuitive Surgical is seeking a Staff Supplier Quality Engineer to lead global 3PL quality oversight and audits, ensuring GDP, ISO 13485, and regulatory compliance across distribution networks. You will design qualification frameworks and drive continuous improvement in 3PL quality controls.

The role requires lead audit experience, cross-functional collaboration, and the ability to manage CAPA/SCAR processes with a focus on 3PL reliability and regulatory readiness.