[Hiring] Staff Supplier Quality Engineer @Intuitive

Role Description

The Staff Supplier Quality Engineer operates with a high degree of independence to determine methodologies, audit frameworks, quality systems, and procedural controls across the global supply chain ecosystem, reporting to the Director, Global Supply Chain Audits.

This role is responsible for the technical execution, continuous improvement, strategic projects, and global harmonization of Third-Party Logistics (3PL) quality management, distribution center controls, and service supplier qualification processes worldwide. The Staff SQE leads risk-based lead audit programs, ensures conformance to applicable global regulatory standards (21 CFR Part 820, ISO 13485, EU MDR 2017/745, Good Distribution Practice / GDP), and serves as a subject matter expert (SME) in regulatory body inspections. S/he partners with cross-functional global operations, logistics, and regional RAQA organizations to drive critical process improvement projects, resolve systemic quality issues, ensure CAPA effectiveness, and advance 3PL supply chain compliance maturity.

Qualifications

• ISO 13485 Lead Auditor with demonstrated experience leading multi-site external audits worldwide.
• Expert-level knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and Good Distribution Practice (GDP / GMP) requirements applicable to 3PL, logistics, and service supplier controls.
• Proven experience leading quality oversight and audits of global 3PLs, cold chain storage, distribution networks, and service suppliers.
• Expert proficiency with QMS platforms including Trackwise, SAP, and Agile for supplier file management, SCAR tracking, and audit scheduling.
• Strong understanding of risk management principles (ISO 14971) as applied to 3PL risk stratification, logistics risk assessments, and audit frequency determination.

Requirements

• BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline preferred.
• Typically requires a minimum of 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or a PhD with 5 years of experience; or equivalent demonstrated experience.
• Significant experience in a high-volume, globally distributed medical device or GxP-regulated company is required.

Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
• Remote work flexibility.

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.