Design Quality Engineer

GE HealthCare UK

01, OH, United States
Design control regulations
Fda cfr 21 820
Iso 13485:2016
The Design Control Specialist is responsible for adherence to the MIM software Quality Management System

Job Summary

  • The Design Control Specialist is responsible for adherence to the MIM software Quality Management System.
  • By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions.
  • GE HealthCare is a leading global medical technology and digital solutions innovator.

Matching Summary

The Design Control Specialist is responsible for adherence to the MIM software Quality Management System.

Skills & Requirements

Must-have

  • Design Control regulations
  • FDA CFR 21 820
  • ISO 13485:2016
  • MDSAP
  • Risk Management ISO standards
  • Software as a Medical Device (SaMD)

Nice-to-have

  • Cross-functional collaboration
  • Critical thinking skills
  • Problem-solving skills
  • Process improvement skills

Key Requirements

  • Bachelor's degree
  • 6 years Quality Assurance experience
  • Medical Devices or Pharmaceuticals experience
  • Legal authorization to work in the U.S.

Work Rights

Legal authorization to work in the U.S.

Tailored Resume

Cover Letter