Medical Device & Quality Engineer

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.

Requirements:

• CE Marking experience.
• Good team players work cross functionally with Engineering and Quality.
• Solid understanding of regulatory standards & requirements (13485, MDR and FDA).
• Experience managing Quality Management System documents and systems.