Quality Engineer Ii-2

Integer

Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
This role involves performing advanced quality engineering work within the medical device industry to ensure product design and manufacturing compliance

Job Summary

  • This role involves performing advanced quality engineering work within the medical device industry to ensure product design and manufacturing compliance.
  • The successful candidate will lead test method validations, manage non-conforming material processes, and support regulatory inspections and audits.
  • Integer is a global organization focused on innovation and customer success, seeking engineers who embody values like candor, integrity, and inclusion.

Matching Summary

This role involves performing advanced quality engineering work within the medical device industry to ensure product design and manufacturing compliance.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • ISO QSR FDA regulations knowledge
  • Device History Records maintenance
  • CAPA and root cause analysis
  • Test method validation protocols

Nice-to-have

  • Continuous improvement suggestions
  • 5 Sigma journey participation
  • Positive can-do attitude
  • Cross-functional collaboration skills
  • Microsoft Office proficiency

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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