Quality Engineer Ii-1

The Integer Group

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Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
** The Integer Group is seeking a Quality Engineer II to support and enhance quality management within the medical device manufacturing sector. The role involves applying engineering principles to ensure compliance with quality standards and regulations while fostering a culture of collaboration and innovation. **

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 ensure internal and external customer expectations are met by adhering to FDA regulations, company policies, and Quality Management Systems.
  • This role requires leading the generation of protocols for test method validations and participating in plant CAPA activities to analyze data trends.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Quality Engineer II to support and enhance quality management within the medical device manufacturing sector. The role involves applying engineering principles to ensure compliance with quality standards and regulations while fostering a culture of collaboration and innovation. **

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience in quality engineering
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and Device History Records
  • Ability to lead test method validations

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environment
  • Experience with continuous improvement methodologies
  • Familiarity with Microsoft Office suite
  • Calm demeanor under pressure

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience (or 7+ without degree)
  • Awareness of domestic and international regulations (ISO, QSR, UL)

Work Rights

Not specified

Tailored Resume

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