Design Quality Engineer

1 month ago


Canton, United States Catalyst Life Sciences Full time

Opportunity to join a leader in medical laboratory equipment focused on new product development. As part of their Quality team, this role will be covering design controls, design assurance, writing requirements, and design traceability within a company that are steadily growing out their operations and QARA team.


Main Responsibilities:

  • Assure new products exceed customer expectations and meet applicable standards by applying expert knowledge of quality principles and tools.
  • Supporting project team activities toward meeting NPD deliverables including requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.


Experience Required

  • 4 years’ experience in Quality Engineering within the Medical Devices industry.
  • In depth knowledge of ISO 13485 and 21 CFR 820, as well as design controls and validation.
  • Bachelor's in a relevant field.


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