3PL Quality Auditor & Supplier Compliance Lead (Remote)

Intuitive Surgical, Inc.; Peachtree Corners (GA); Remote; USD 183,000 - 263,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Staff Supplier Quality Engineer to lead global 3PL quality controls, audits, and supplier qualification efforts.

You will coordinate risk-based audits, ensure GDP, ISO 13485, and CFR compliance, and drive continuous improvements with cross-functional teams across the supply chain. Responsibilities include leading audit programs, maintaining QA documentation, and mentoring junior staff in a regulated medical device environment.

Qualifications

• ISO 13485 Lead Auditor with multi-site audit leadership experience.
• In-depth knowledge of 21 CFR Part 820, ISO 13485, EU MDR 2017/745, GDP.
• Proven audits of global 3PLs, cold chain, and service suppliers.
• Expert use of Trackwise, SAP and Agile for supplier file management.
• Strong understanding of risk management per ISO 14971.

Responsibilities

• Lead global 3PL quality oversight and 3PL program design.
• Own audit master schedules, risk models, protocols, and reports.
• Conduct Lead Audits against GDP, ISO 13485 and related standards.
• Drive CAPA and SCAR processes with 3PL leadership.

Skills

Auditing

Regulatory compliance

3PL quality management

QMS software (Trackwise, SAP, Agile)

Risk management (ISO 14971)

Education

BS/BA in Engineering, Life Sciences, or related

Tools

Trackwise

SAP

Agile

Job description

Intuitive Surgical, Inc. is seeking a Staff Supplier Quality Engineer to lead global 3PL quality controls, audits, and supplier qualification efforts.

You will coordinate risk-based audits, ensure GDP, ISO 13485, and CFR compliance, and drive continuous improvements with cross-functional teams across the supply chain. Responsibilities include leading audit programs, maintaining QA documentation, and mentoring junior staff in a regulated medical device environment.