Quality Engineer Ii-1

Integer

Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms 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 of protocols for test method validations and coordinate process validations with Manufacturing Engineers.

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
  • FDA regulations and QMS knowledge
  • ISO and QSR standards awareness
  • Root cause analysis and CAPA
  • Device History Records maintenance
  • Test method validation protocols

Nice-to-have

  • Strong written and oral communication
  • Positive can-do attitude
  • Collaborative team player
  • Calm demeanor in high energy
  • Continuous improvement ideation
  • Microsoft Office proficiency
  • 5S workplace organization

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of FDA regulations and ISO standards

Work Rights

Not specified

Tailored Resume

Cover Letter