Senior Quality Engineer

Dynamic start-up medical device firm located in the SF Bay Area seeks individual to join its quality engineering organization.

Responsibilities will include serving as subject matter expert in Quality Engineering to R&D and Manufacturing/Operations in supporting product development and manufacturing activities(including process validations, equipment qualifications, master validation plans, product quality plans, device history records, in-process quality monitoring, manufacturing scale-up activities, and environmental monitoring). The technology consists of implants and catheter delivery systems to address mitral valve regurgitation.

This firm is currently conducting clinical trials OUS.