3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
Integer is seeking a Quality Engineer II to enhance patient care through quality assurance in medical device manufacturing. The role focuses on utilizing advanced engineering methods to ensure compliance with safety and regulatory standards while promoting continuous improvement
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 inspections, monitor manufacturing compliance, and ensure complete Device History Records are maintained according to DMR specifications.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.
Matching Summary
Match Score: 85
Integer is seeking a Quality Engineer II to enhance patient care through quality assurance in medical device manufacturing. The role focuses on utilizing advanced engineering methods to ensure compliance with safety and regulatory standards while promoting continuous improvement.
Salary
Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program included; Benefits: Comprehensive package with immediate eligibility including medical, dental, vision, 401(k) match
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 investigations and root cause analysis
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environment
Experience with Microsoft Office suite
Collaborative team player with cross-functional focus
Calm demeanor under production pressure
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years of relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)