Company Overview
Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. 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.
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. 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 integral regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820.
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.
Monitor and trend Quality Management System nonconformances and quality data for escalations.
Drive training activities and tracking to ensure compliance with all applicable regulations and key performance indicators.
Assist with generation, analysis, and presentation of quality metrics.
Support document control activities, including review, approval, and change management within the electronic QMS.
Ensure adherence to company procedures and applicable regulatory and quality standards.
Support additional quality system activities as assigned.
Bachelor's degree in engineering, medical, science, or equivalent experience. . Minimum of 3

📌 Quality Assurance Specialist/QA Specialist (Naucalpan de Juárez)
🏢 Outset Medical
📍 Naucalpan de Juárez