Quality Complaint Analyst

Company Overview 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 Responsible 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. This role works closely with cross-functional partners, including Customer Support, Engineering, Service, and Medical/Clinical advisors, to ensure accurate documentation, timely investigations, and appropriate reportability assessments in accordance with established procedures and regulatory requirements. Essential Job Functions and Responsibilities • Contribute to continuous improvements to Complaint Handling process. • Provides information for timely Adverse Event reporting. • Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint. • Collaborate with Customer Support, Engineering, and Service teams to support complaint activities. • Perform reportability determinations in conjunction with medical advisor as necessary. • Be part of the Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • The role requires awareness of new or revised regulations and/or guidelines. • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance. • Support of additional Quality Systems activities, as requested. • Support additional activities, as assigned. Required Qualifications • Bachelor’s Degree in engineering or technical field or equivalent. • Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements. • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. • Minimum of 1 year experience working in a regulated industry or similar manufacturing and engineering environments preferred. • Ability to work effectively in a fast paced and dynamic environment. • Strong analytical skills. • Proficient in MS Office, Visio, and Adobe Acrobat. • Fluent in English (both written and verbal). Desired Qualifications . • Excellent interpersonal skills. • A self-starter, mot