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

Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA's, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders. Contractor ́s management, such as external laboratories and sterilization sites.

Quality

Inspectors management. Analyzes and performs failure analysis to non-conforming products. Leads in the implementation of assurances, process controls, nonconformances and CAPA. Reviews and participates in the update/creation process FMEA's, application FMEA's, and risk benefit analysis for medical devices.





Develops and prepares monthly quality trend analysis and reports. Leads, coaches, and mentors non-exempt and entry level exempt personnel. Bachelor's degree in engineering or technical field or equivalent experience is required.

Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. Able to read and understand technical data. Competent using Microsoft Office suites. Strong written and verbal communication in English.

Statistical analysis software a plus. Quality engineering certification, Lean Six Sigma certification. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.

And we believe that it begins with YOU, our future Outsetter. 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.

📌 Remote Senior Quality Engineer (Lerdo)
🏢 Outset Medical
📍 Lerdo