Design Qa Engineer Ii

Danaher

Dalian, China
Design control quality assurance
Iso 13485
Gmp
Responsible for quality assurance of design control, monitoring design control, coordinating and tracking design defects, and driving quality improvement projects from design control

Job Summary

  • Responsible for quality assurance of design control, monitoring design control, coordinating and tracking design defects, and driving quality improvement projects from design control.
  • Ensure design control process compliance throughout the whole product lifecycle, review and approve DHF, and establish, maintain, and continually improve QMS to meet regulation requirements.
  • Monitor QMS process performance with data analysis, lead quality improvement projects from a system level, and offer quality training.

Matching Summary

Responsible for quality assurance of design control, monitoring design control, coordinating and tracking design defects, and driving quality improvement projects from design control.

Skills & Requirements

Must-have

  • design control quality assurance
  • ISO 13485
  • GMP
  • QMS maintenance
  • product lifecycle compliance

Nice-to-have

  • risk management processes
  • FDA audit experience
  • system-level core team support
  • CAPA implementation

Key Requirements

  • 2+ years exp. with Bachelor's degree
  • 0-2 years exp. with Master's degree
  • 5+ years software quality management experience
  • Fluent in spoken English

Work Rights

Not specified

Tailored Resume

Cover Letter