Quality Engineer Ii-2

Integer

**
Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
** Integer is seeking a Quality Engineer II to enhance their medical device manufacturing processes. The role focuses on applying quality engineering methods, supporting compliance with regulations, and contributing to continuous improvement efforts while promoting the company's core values. **

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 lead the generation and completion of protocols for test method validations and coordinate process validations with Manufacturing Engineers.
  • You are expected to ensure compliance with FDA regulations, ISO standards, and maintain complete Device History Records for assigned products.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer II to enhance their medical device manufacturing processes. The role focuses on applying quality engineering methods, supporting compliance with regulations, and contributing to continuous improvement efforts while promoting the company's core values. **

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years relevant experience
  • Knowledge of Domestic and International Regulations (ISO, QSR, UL)
  • Microsoft Office proficiency

Work Rights

Not specified

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