The Design Quality Engineer provides leadership ensuring compliance with respect to domestic and international regulations. Acts as a subject matter expert in all aspects of device product development. This is a well funded start up opportunity with a product that has been FDA identified as a Breakthrough device. Plans, coordinates and develops quality programs designed to ensure products are consistent with established standards by performing the following duties during the medical device/combination product design process and through commercialization and post market surveillance. Responsible for identification and implementation of continuous system improvements including KPI metrics, oversight of critical quality systems as assigned and disposit
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