Supplier Quality Engineer

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.

Job Description

Primary Function of Position The Supplier Quality Engineer (SQE) reports to the Manager, Global Supplier Quality and is responsible for ensuring compliance of Intuitive's Supplier Controls with applicable regulations and standards including ISO 13485:2016, MDSAP, and EU MDR. The SQE partners with cross-functional teams — Purchasing, Product Quality, Supplier Development, and Supplier Engineering — to improve Supplier Controls Business Processes. Key functions include conducting key Supplier Audits as Lead Auditor, Supplier Monitoring Boards, managing Internal CAPAs related to supplier controls, driving high-visibility SCARs. Essential Job Duties

• Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit Schedule, including Pre-Audit activities and Post-Audit actions.
• Execute Audit Reports with necessary Audit Response Forms and Supplier Responses.
• Own Supplier Quality processes including Supplier Controls, Global Supplier Manual, Supplier Selection, Evaluation and Re-Evaluations, SCAR Process, and Supplier Monitoring as a Corporate Business Process Owner.
• Run quarterly Supplier Monitoring Boards with cross-functional stakeholders, presenting Supplier Quality health metrics on Audits, SCARs, Supplier nonconformances, and ASL.
• Periodically analyze and review Supplier Controls processes in partnership with Regulatory Affairs/Quality Systems team to maintain compliance with latest applicable Regulations and Standards.
• Lead internal CAPAs related to Supplier Controls.
• Lead high-visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as Lead Auditor.
• Guide Process Managers on ASL maintenance and Supplier promotions and removals.
• Support Internal and External Audits (FDA, MDSAP, EU MDR, etc.) representing Supplier Quality in Audit Front Rooms.
• Lead Projects as Project Manager to improve Supplier Controls Processes for efficiency and compliance.
• Serve as technical custodian of Supplier Data Monitoring and Analysis; analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.
• Review and Approve Product SCARs; serve as board member for SCAR Review Boards.
• Provide guidance to International Intuitive Sites on Local/Regional Supplier Controls execution and maintenance.
• Provide guidance to NPI Project teams on Supplier Selection and onboarding.
• Guide Purchasing department on Quality elements of Supplier Agreement negotiations.