Quality Engineer Ii

Integer

Trenton, GA, United States
Quality management systems (qms)
Fda regulations
Device history records (dhr)
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry

Job Summary

  • The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry.
  • You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, cash-based incentive program, and a comprehensive benefits package.

Matching Summary

The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • test method validations
  • process validations
  • non-conforming material process

Nice-to-have

  • positive can-do attitude
  • calm demeanor
  • continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field and 3 years relevant experience
  • 7+ years relevant experience if education requirement not met
  • Awareness of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter