Description
The Quality Engineer supports Capstan Medical's mitral and/or tricuspid structural heart valve products from development through manufacturing readiness and production. The role partners with R&D, Operations, Manufacturing, Regulatory Affairs, and Quality to manage design controls, risk management, sterilization, microbiology testing, acceptance activities, release processes, cleanroom manufacturing, NCR/MRB/CAPA, audits, and continuous improvement. The position requires a bachelor's degree in a relevant technical field, at least five years of medical device quality engineering experience, and onsite work with cross-functional teams.
