Quality Engineer Ii-1

The Integer Group

**
Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms knowledge
** The Integer Group is seeking a Quality Engineer II to enhance product quality in the medical device sector. This role involves applying engineering principles to solve quality issues, supporting compliance with regulations, and contributing to continuous improvement initiatives. **

Job Summary

  • This role involves performing advanced quality engineering tasks within the medical device industry to ensure product integrity and regulatory compliance.
  • The successful candidate will lead test method validations, manage non-conforming material processes, and support internal and external audits.
  • Integer is a global organization committed to innovation and customer success, offering a culture that embraces uniqueness and long-term growth.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Quality Engineer II to enhance product quality in the medical device sector. This role involves applying engineering principles to solve quality issues, supporting compliance with regulations, and contributing 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
  • Test method validation protocols

Nice-to-have

  • Continuous improvement mindset
  • Collaborative team player
  • Strong written communication
  • Positive can-do attitude
  • Experience with 5 Sigma methodology

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of FDA, ISO, and QSR regulations
  • Proficiency in Microsoft Office
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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