Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.

At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview





The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS). This role supports quality system processes including document control, training, change control nonconformance, and CAPA activities. The specialist monitors quality metrics, assists with audits, and ensures compliance with applicable general regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820.

Essential Job Functions and Responsibilities
- Support monitoring and continuous improvement of Quality Management System processes.
- Collaborate with Engineering, Manufacturing, and Quality teams on the development and sustaining of quality processes.
- Support internal and external audit preparation and execution activities.
- Monitor and trend Quality Management System nonconformances and quality data for escalations.
- Drive training activities and trac

📌 Quality Systems Specialist (Tijuana)
🏢 Outset Medical
📍 Tijuana