Quality Engineer Ii-1

Integer

**
Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms knowledge
** Integer is seeking a Quality Engineer II to support the development and application of quality engineering methods within the medical device industry. The role involves ensuring compliance with quality management systems, participating in continuous improvement efforts, and collaborating with cross-functional teams to enhance product quality and manufacturing processes. **

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 lead the generation and completion of protocols for test method validations and coordinate process validations with Manufacturing Engineers.
  • The role requires ensuring compliance with FDA regulations, Quality Management Systems (QMS), and supporting regulatory inspections and audits.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer II to support the development and application of quality engineering methods within the medical device industry. The role involves ensuring compliance with quality management systems, participating in continuous improvement efforts, and collaborating with cross-functional teams to enhance product quality and manufacturing processes. **

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
  • Device History Records maintenance

Nice-to-have

  • Continuous improvement mindset
  • Collaborative team player
  • Positive can-do attitude
  • Strong written communication
  • 5 Sigma journey participation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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