.**Company Overview**Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.**Position Overview**Responsible for monitoring and managing all areas of Complaint Handling activities. Monitors metrics and drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Initiate and facilitate corrective or preventive actions as needed. Ensure quality customer and regulatory communications for current products. Assist in ensuring compliance with evolving Global Requirements and Regulations such as MDSAP and EUMDR. The incumbent for this position will support additional activities as assigned.**Essential Job Functions and Responsibilities**- 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. Contribute to continuous improvements to Complaint Handling process.- 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.- 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.- Provides information for timely Adverse Event reporting.- 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- Excellent interpersonal skills- A self-starter, motivated and able to positively motivate others- Focused, target driven with a positive, can-do attitude- Support of additional Quality Systems activities, as requested