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Quality Engineer

SoloPoint Solutions - Midwest
Germantown, WI Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/15/2025

Qualifications :

  • High School Diploma or equivalent is required.
  • BS degree in engineer or business is preferred.
  • Three to five years of experience and / or training, or equivalent combination of education and experience.
  • Demonstrated experience in problem solving.
  • Demonstrated statistical analysis skills.
  • GD&T experience.
  • Experience in working with teams to achieve results.
  • Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.

Requirements :

  • Support engineering change process.
  • Interface with customer to ensure compliance to customer request and requirements.
  • Manage product inspection and testing activities.
  • Update production documents including control plan, PFMEA, visual inspection
  • Generate quality plans for new product launches
  • Maintain the Quality Management System (QMS).
  • Approve product for shipment.
  • Requirements for Medical Product Focus

  • Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
  • Understand 21 CFR Part 820 Quality System Regulation – Good Manufacturing Practice for the Medical Devices.
  • Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.
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