Qa Specialist

GEHC

Multiple Locations
Medical device quality management system
Fda 21 cfr 820
Iso 13485:2016
The QA Specialist II will support Document Control, CAPA system, Risk Management, QMS activities and Complaints Management to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software

Job Summary

  • The QA Specialist II will support Document Control, CAPA system, Risk Management, QMS activities and Complaints Management to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software.
  • 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. Our mission is to improve lives in the moments that matter.

Matching Summary

The QA Specialist II will support Document Control, CAPA system, Risk Management, QMS activities and Complaints Management to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software.

Skills & Requirements

Must-have

  • Medical Device Quality Management System
  • FDA 21 CFR 820
  • ISO 13485:2016
  • MDSAP compliance
  • Root cause analysis
  • Cross-functional collaboration

Nice-to-have

  • Strong critical thinking skills
  • Influencing skills
  • Problem-solving skills
  • Project management skills
  • Effective communication

Key Requirements

  • Bachelor's degree or equivalent experience
  • 4+ years Quality Assurance experience
  • Medical Device or Pharmaceutical industry experience
  • Software as a Medical Device (SaMD) experience preferred
  • Legal authorization to work in the U.S.

Work Rights

Legal authorization to work in the U.S.

Tailored Resume

Cover Letter