Quality Engineer Ii-2

The Integer Group

Not specified (assumed to be hybrid or onsite based on industry standards).
Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
The Integer Group is seeking a Quality Engineer II who will utilize advanced quality tools to ensure compliance with regulatory standards within the medical device industry. The ideal candidate should possess a bachelor’s degree in engineering or a related field, along with relevant experience, demonstrating the ability to work both independently and collaboratively in a dynamic environment

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 and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
  • You are expected to lead the generation and completion of protocols and reports for test method validations while ensuring adherence to Integer's Values.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer II who will utilize advanced quality tools to ensure compliance with regulatory standards within the medical device industry. The ideal candidate should possess a bachelor’s degree in engineering or a related field, along with relevant experience, demonstrating the ability to work both independently and collaboratively in a dynamic environment.

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

Nice-to-have

  • Continuous improvement suggestions
  • 5 Sigma journey participation
  • Cross-functional collaboration skills
  • Positive can-do attitude
  • Microsoft Office proficiency

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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