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. Position OverviewResponsible for the execution and maintenance of the complaint handling process by actively managing product complaints throughout their full lifecycle, from intake through investigation and closure. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.Support additional Quality Systems activities, as requested.Required QualificationsBachelor's degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field.Minimum of 2 years of relevant experience in the medical device industry required, preferably in Quality Assurance, Complaint Handling,



or Post-Market Surveillance.Working knowledge of FDA Quality Management System Regulation (QMSR), ISO **, and applicable U.S. medical device regulatory requirements.Familiarity with FDA Medical Device Reporting requirements (21 CFR Part 803) and medical device complaint handling processes.Understanding of Good Manufacturing Practices (GMP), quality management systems, and documentation practices.Familiarity with complaint investigations, root cause analysis, and Corrective and Preventive Actions (CAPA). Proficiency in Microsoft Office; experience with electronic Quality Management Systems (eQMS) is a plus.Fluency in English, both written and verbal.At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams.If you are unsure about the authenticity of a communication, contact us immediately at *** . We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws.

📌 Quality Auditor I (México)
🏢 Outset Medical
📍 México