Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA (Fully Remote)

Intuitive; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Intuitive, a leader in robotic-assisted surgery, seeks a dedicated ISO 13485 Lead Auditor to oversee global 3PL audits and regulatory compliance in the United States. You will serve as a subject matter expert during inspections and drive CAPA/SCAR actions while guiding continuous improvements across the QMS landscape.

Ideal candidates will have proven experience auditing global 3PLs, including cold chain operations, and will lead cross-functional teams to ensure adherence to quality standards.

Qualifications

• Experience auditing global 3PLs and cold chain operations.

Responsibilities

• Own global 3PL Quality Program and drive CAPA/SCAR processes.
• Manage QMS platforms and lead continuous improvement projects.

Skills

Auditing global 3PLs

Cold chain operations

Job description

• Lead global 3PL and service supplier audits as ISO 13485 Lead Auditor.
• Ensure regulatory compliance and act as SME during inspections.

Key Responsibilities:

• Own global 3PL Quality Program and drive CAPA/SCAR processes.
• Manage QMS platforms and lead continuous improvement projects.

Qualifications:

• Experience auditing global 3PLs and cold chain operations.

Intuitive

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies such as the da Vinci surgical system. The company brings together engineers, clinicians, and innovators focused on making surgery smarter, safer, and more human.