Staff Supplier Quality Engineer - Global 3PL Audits (Remote)

Intuitive Surgical; United States; Remote; USD 156,000 - 264,000; Full time

Job summary

Intuitive Surgical in United States is seeking a Staff Supplier Quality Engineer to lead global 3PL quality management, audits, and supplier qualification programs. You will drive CAPA effectiveness, regulatory conformance (FDA, ISO, GDP), and harmonize quality controls across regions.

Responsibilities include leading audits, developing QA frameworks, and mentoring junior staff while partnering with RAQA and IT teams to optimize QMS platforms like Trackwise, SAP, and Agile.

Qualifications

• ISO 13485 Lead Auditor with multi-site external audits.
• Expert knowledge of 21 CFR Part 820, ISO 13485, EU MDR 2017/745, GDP/GMP requirements.
• Proven experience auditing global 3PLs, cold chain storage, and service suppliers.

Responsibilities

• Lead global 3PL quality management and audits.
• Design and maintain 3PL audit master schedules and risk models.
• Drive CAPA and SCAR closure with cross-functional partners.
• Support FDA inspections and Notified Body audits as SME.
• Manage Trackwise, SAP, and Agile for supplier file management.

Skills

Lead Auditor

Regulatory knowledge

Audit leadership

Risk management

Education

BS/BA in Engineering or Life Sciences

MS/PhD considered

Tools

Trackwise

SAP

Agile

Job description

Intuitive Surgical in United States is seeking a Staff Supplier Quality Engineer to lead global 3PL quality management, audits, and supplier qualification programs. You will drive CAPA effectiveness, regulatory conformance (FDA, ISO, GDP), and harmonize quality controls across regions.

Responsibilities include leading audits, developing QA frameworks, and mentoring junior staff while partnering with RAQA and IT teams to optimize QMS platforms like Trackwise, SAP, and Agile.