Global 3PL Quality Auditor & ISO 13485 Lead

Regulatory Jobs; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Intuitive Surgical is seeking a Staff Supplier Quality Engineer to lead worldwide 3PL quality management and audits. The role requires expert understanding of GDP, ISO 13485, and 21 CFR Part 820, with oversight of CAPAs and supplier qualifications in a fast-paced medical device environment.

The position partners with global operations and RAQA to drive continuous improvement and regulatory compliance across distribution networks and service providers.

Qualifications

• BS/BA in Engineering, Life Sciences, or Supply Chain Management (or related field) required.
• 12+ years of related experience in a high-volume, GxP-regulated environment typical.
• Extensive knowledge of regulatory standards: 21 CFR Part 820, ISO 13485, EU MDR 2017/745, GDP.

Responsibilities

• Lead global 3PL quality management programs and audits across regions.
• Drive CAPA, SCARs, risk-based audits, and supplier qualifications.
• Coordinate with IT and QA on QMS platforms (Trackwise, SAP, Agile) for supplier workflows.
• Provide regulatory audit support and act as SME during FDA/Notified Body inspections.
• Mentor junior staff and oversee supplier quality activities.

Education

BS/BA in Engineering, Life Sciences, or Supply Chain Management

Tools

Trackwise

SAP

Agile

Job description

Intuitive Surgical is seeking a Staff Supplier Quality Engineer to lead worldwide 3PL quality management and audits. The role requires expert understanding of GDP, ISO 13485, and 21 CFR Part 820, with oversight of CAPAs and supplier qualifications in a fast-paced medical device environment.

The position partners with global operations and RAQA to drive continuous improvement and regulatory compliance across distribution networks and service providers.