Roles & Responsibilities:Quality Engineer withs strong medical device experience and PRODUCT QUALITY. MUST have experience with Class III/Implantable medical device(s).Experience maintaining/working within an ISO 13485 Quality Management System (QMS)Experience with CAPA Process.CE Marking experience.Good team player works cross functionally with Engineering and Quality.Solid understanding of regulatory standards & requirements (13485, MDR and FDA).Experience managing Quality Management System documents and systems.
