Quality Engineer I

Who Are We? Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes. This is precision cardiology, and we know it’s within reach. What Will You Do? The Overview The Quality Engineer I is responsible to support production activities including Quality Control activities for components and suppliers, in-process and finished goods inspection and release, and the transfer of products/processes from Design to Production. This role reports to the Director, Quality Management Systems working on the Regulatory, Quality, and Clinical Development Operations Team. This is a hybrid role based in our Chicago office. The Specifics Ensure specifications for components are complete and accurate prior to acceptance activities. Ensure suppliers for components and services that may impact product quality are formally qualified and documented as such. Perform quality inspections of finished goods and device history records, and release goods, if accepted. Support environmental monitoring activities. Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production. Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation. Perform monitoring and measurement activities, reporting regularly to the Director, QMS, and to Management via Management Review processes. Why Prolaio? Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology. Innovative Environment: You will be p...