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ENGINEERING: Quality Assurance Engineer - Manufacturing

KEB America Inc

KEB America Inc

Quality Assurance
Shakopee, MN, USA
Posted 6+ months ago

The Quality Engineer is responsible for coordinating medical device customers’ needs and requirements, as well as handling Major Quality Miscue (MQM) forms.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

  • Work closely with customers to address complaints or concerns
  • Handle customer returns and change requests
  • Create control plans
  • Create, update, and modify PFMEAs
  • Troubleshoot and analyze internal failures
  • Assist in testing and validation activities
  • Create and document Major Quality Miscue (MQM) forms
  • Create corrective action reports
  • Document and analyze in process failures and rejections (MRB)
  • Analyze and report production and test system data
  • Perform random inspections
  • Create forms, templates, work instructions, or testing procedures
  • Coordinate with and assist other departments
  • Follow safety rules and keep clean/orderly work area
  • Perform other duties as required or assigned