Quality Engineer Ii-1

The Integer Group

Not specified (assumed hybrid)
Bachelor's degree in engineering
3 years relevant experience
Knowledge of fda regulations and iso standards
The Integer Group is seeking a Quality Engineer II to enhance the quality assurance processes within the medical device manufacturing sector. This position emphasizes collaboration, innovation, and adherence to regulatory standards while fostering a culture of integrity and customer focus

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 inspections, monitor manufacturing compliance with DMR, and ensure complete Device History Records are maintained.
  • You will lead the generation of protocols for test method validations and manage non-conforming material dispositions to prevent re-occurrence.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer II to enhance the quality assurance processes within the medical device manufacturing sector. This position emphasizes collaboration, innovation, and adherence to regulatory standards while fostering a culture of integrity and customer focus.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and CAPA processes
  • Ability to lead test method validations

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude
  • Experience with continuous improvement projects
  • Calm demeanor in high-energy environments
  • Collaborative team player

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Awareness of domestic and international regulations (ISO, QSR, UL)
  • Good knowledge of Microsoft Office

Work Rights

Not specified

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