Quality Engineer Ii-2

The Integer Group

Not specified (assumed to be hybrid/remote 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 to enhance product quality within the medical device sector. The role involves applying engineering principles to resolve issues, supporting regulatory compliance, and collaborating on continuous improvement initiatives

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 collaborate with others in the exchange of information and regularly check for understanding in support of your development as an engineer.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer II to enhance product quality within the medical device sector. The role involves applying engineering principles to resolve issues, supporting regulatory compliance, and collaborating on continuous improvement initiatives.

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 device history records
  • Ability to lead CAPA and complaint investigations

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environments
  • Experience with continuous improvement methodologies
  • Proficiency in Microsoft Office applications
  • Collaborative team player with cross-functional experience

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 3 years relevant experience required
  • Awareness of domestic and international regulations (ISO, QSR, UL)
  • 7+ years experience if no degree held

Work Rights

Not specified

Tailored Resume

Cover Letter