Quality Engineer Ii-2

The Integer Group

Not specified (potential for hybrid or onsite based on industry standards)
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-2 to join their team, focusing on quality assurance and engineering within the medical device industry. The ideal candidate will have a bachelor's degree in engineering or related fields, alongside relevant experience, and will contribute to maintaining high-quality standards and compliance with regulations

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 are expected to 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-2 to join their team, focusing on quality assurance and engineering within the medical device industry. The ideal candidate will have a bachelor's degree in engineering or related fields, alongside relevant experience, and will contribute to maintaining high-quality standards and compliance with regulations.

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 CAPA processes
  • 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 5S and visual controls
  • Collaborative team player mindset

Key Requirements

  • Bachelor's degree in engineering
  • 3+ years relevant experience
  • Knowledge of FDA and ISO regulations
  • 7+ years experience if no degree

Work Rights

Not specified

Tailored Resume

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