Quality Engineer Ii-1

Integer

Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry

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 Quality Management Systems.

Matching 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.

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 suggestions
  • 5 Sigma journey participation
  • Cross-functional collaboration skills
  • Positive can-do attitude
  • Visual controls and 5S adoption

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Awareness of ISO, QSR, UL, MDD, TGA standards
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

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