Actalent
Maple Grove, MN, USA
Job Title: Senior Quality EngineerJob Description The Senior Manufacturing Quality Engineer is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role is to ensure the design assurance of a heart valve and a delivery catheter system. This position requires a background in the medical device industry, particularly in cardiological devices, including implantable heart valves and transcatheter delivery systems, along with a strong understanding of regulations and standards such as 21 CFR 820. Responsibilities Lead the product development process including key design assurance activities, design reviews, verification and validation activities, development and validation of testing methods, management of product requirements, test case tracing, and risk management. Facilitate the transition of new product development into production. Conduct reviews and enhancements of Quality...


