Quality Engineer Ii-1

The Integer Group

Not specified
Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms knowledge
The Integer Group is seeking a Quality Engineer II who will apply advanced quality engineering tools in the medical device industry to ensure compliance with regulations and enhance product quality. The ideal candidate will have a bachelor's degree in engineering or a related field, with at least three years of relevant experience, and will contribute to continuous improvement initiatives

Job Summary

  • The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
  • You will support regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
  • You are expected to lead the generation and completion of protocols for test method validations and coordinate process validations with Manufacturing Engineers.

Matching Summary

Match Score: 75

The Integer Group is seeking a Quality Engineer II who will apply advanced quality engineering tools in the medical device industry to ensure compliance with regulations and enhance product quality. The ideal candidate will have a bachelor's degree in engineering or a related field, with at least three years of relevant experience, and will contribute to continuous improvement initiatives.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • FDA regulations and QMS knowledge
  • ISO and QSR standards awareness
  • Root cause analysis skills
  • Device History Record maintenance

Nice-to-have

  • Continuous improvement mindset
  • Cross-functional collaboration
  • Positive can-do attitude
  • Data analysis proficiency
  • 5S workplace organization

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

Work Rights

Not specified

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