3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
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Integer is seeking a Quality Engineer II to support the medical device industry by ensuring compliance with quality standards and regulations. The ideal candidate will have relevant engineering experience, a bachelor's degree, and strong communication skills, contributing to the company's commitment to innovation and excellence.
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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 and correct Device History Records are maintained.
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: 75
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Integer is seeking a Quality Engineer II to support the medical device industry by ensuring compliance with quality standards and regulations. The ideal candidate will have relevant engineering experience, a bachelor's degree, and strong communication skills, contributing to the company's commitment to innovation and excellence.
**
Salary
Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 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 CAPA processes
Ability to lead test method validations
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environment
Collaborative approach with cross-functional teams
Experience with continuous improvement methodologies
Calm demeanor under pressure
Key Requirements
Bachelor's degree in engineering
3 years relevant experience
7+ years experience if no degree
Knowledge of Domestic and International Regulations