Medical Device & Quality Engineer Job at Katalyst HealthCares and Life Sciences, Ypsilanti, MI

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  • Katalyst HealthCares and Life Sciences
  • Ypsilanti, MI

Job Description

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.

Job Tags

Full time,

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