Quality Engineer Ii-1

The Integer Group

**
Bachelor's degree in engineering
3 years relevant experience
Iso and qsr regulatory knowledge
** The Integer Group is seeking a Quality Engineer II who will apply advanced quality engineering principles within the medical device industry, ensuring compliance with various regulatory standards while supporting continuous improvement initiatives. The ideal candidate will possess a bachelor's degree in engineering or related fields with at least three years of relevant experience and demonstrate strong technical aptitude and communication skills. **

Job Summary

  • This role involves performing advanced quality engineering tasks within the medical device industry to ensure product integrity and regulatory compliance.
  • The successful candidate will lead test method validations, manage non-conforming material processes, and support internal and external audits.
  • Integer fosters a culture of innovation and collaboration where employees are expected to adhere to core values like Candor, Integrity, and Customer focus.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Quality Engineer II who will apply advanced quality engineering principles within the medical device industry, ensuring compliance with various regulatory standards while supporting continuous improvement initiatives. The ideal candidate will possess a bachelor's degree in engineering or related fields with at least three years of relevant experience and demonstrate strong technical aptitude and communication skills. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Continuous improvement mindset
  • Cross-functional collaboration skills
  • Positive can-do attitude
  • 5 Sigma journey participation
  • Visual controls (5S) experience

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Proficiency in Microsoft Office
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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