System Configuration Specialist

Terumo Heart, Inc is dedicated to the innovation, introduction and advancement of products to improve the quality of healthcare for heart failure patients. Our principal focus is the development, clinical evaluation and commercialization of the DuraHeart® Left Ventricular Assist System (LVAS). The system is designed to provide long-term circulatory support and address the shortage of donor hearts for cardiac transplantation. Combining patented magnetic-levitation and centrifugal pump technologies, the DuraHeart LVAS is expected to decrease complications and improve the lives of patients with severe heart failure.Terumo Heart, Inc. is a wholly owned subsidiary of Terumo Corporation with headquarters in Ann Arbor Michigan. The team is led by Chisato Nojiri, M.D., Ph.D., a pioneer in the field of mechanical assist devices. Responsible for maintaining the integrity of the Product Data Management (PDM) system and other formalized processes to maintain accurate and traceable document records and product structure information associated with new product design and change orders. Responsible for investigating, planning, and implementing the improvements in and/or additions to quality and manufacturing processes with the end result of producing a better quality product more efficiently. Ensure compliance to Terumos quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures as required. Requires a four-year degree, with 3 years of quality assurance experience, preferred Configuration Management certification/equivalent training and/or CQE, CQA certifications preferred. Proficient skill in commonly used computer software for data management is required.