The Integer Group is seeking a Quality Engineer II to enhance their manufacturing processes and ensure compliance with quality management systems in the medical device industry. The ideal candidate will have a bachelor's degree in engineering or related field, along with experience in quality engineering, and a strong commitment to collaboration and innovation
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 for test method validations and coordinate process validations with Manufacturing Engineers.
Matching Summary
Match Score: 85
The Integer Group is seeking a Quality Engineer II to enhance their manufacturing processes and ensure compliance with quality management systems in the medical device industry. The ideal candidate will have a bachelor's degree in engineering or related field, along with experience in quality engineering, and a strong commitment to collaboration and innovation.
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
Cross-functional collaboration
Positive can-do attitude
Calm demeanor in high energy
Microsoft Office proficiency
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years relevant experience
Knowledge of FDA, ISO, QSR, UL, MDD, TGA regulations