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 contribute to quality assurance in the medical device industry, with a focus on problem-solving and compliance with regulatory standards. The ideal candidate should have a background in engineering, relevant experience, and a strong commitment to the company's values of customer focus, innovation, and collaboration.
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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 lead the generation of protocols for test method validations.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with company matching.
Matching Summary
Match Score: 75
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Integer is seeking a Quality Engineer II to contribute to quality assurance in the medical device industry, with a focus on problem-solving and compliance with regulatory standards. The ideal candidate should have a background in engineering, relevant experience, and a strong commitment to the company's values of customer focus, innovation, and collaboration.
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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 device history records
Proficiency in root cause analysis and CAPA processes
Nice-to-have
Strong written and oral communication skills
Ability to work independently and collaboratively
Positive can-do attitude in high-energy environments
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Key Requirements
Minimum Bachelor's degree in engineering
3+ years of relevant quality engineering experience
Awareness of domestic and international regulations (ISO, QSR, UL)