Quality Engineer Ii-1

The Integer Group

Not specified (assumed to be in-person based on the nature of the role).
Bachelor's degree in engineering
3 years relevant experience
Iso and qsr regulatory knowledge
The Integer Group is seeking a Quality Engineer II to enhance their quality assurance processes in the medical device industry. The ideal candidate will possess strong technical skills, a collaborative spirit, and a commitment to achieving excellence in quality and regulatory compliance

Job Summary

  • This role focuses on performing advanced quality engineering tasks within the medical device industry to ensure product integrity and regulatory compliance.
  • The engineer will lead test method validations, manage non-conforming material processes, and support internal and external regulatory inspections.
  • Candidates are expected to adhere to Integer's core values of Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity while driving continuous improvement.

Matching Summary

Match Score: 75

The Integer Group is seeking a Quality Engineer II to enhance their quality assurance processes in the medical device industry. The ideal candidate will possess strong technical skills, a collaborative spirit, and a commitment to achieving excellence in quality and regulatory compliance.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • ISO and QSR regulatory knowledge
  • FDA regulations compliance
  • Device History Records maintenance
  • FMEA and Control Plan review
  • Test method validation protocols

Nice-to-have

  • Continuous improvement suggestions
  • 5 Sigma journey participation
  • Positive can-do attitude
  • Cross-functional collaboration
  • Visual controls and 5S adoption

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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