3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
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The Integer Group is seeking a Quality Engineer II to enhance its medical device manufacturing processes, focusing on quality assurance and compliance with relevant regulations. The ideal candidate will have a bachelor's degree in engineering or relevant experience, emphasizing innovation, collaboration, and a commitment to quality.
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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 ensure internal and external customer expectations are met by adhering to FDA regulations, company policies, and Quality Management Systems.
You will lead the generation and completion of protocols for test method validations and support non-conforming material processes including complaint investigations.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Quality Engineer II to enhance its medical device manufacturing processes, focusing on quality assurance and compliance with relevant regulations. The ideal candidate will have a bachelor's degree in engineering or relevant experience, emphasizing innovation, collaboration, and a commitment to quality.
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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 Quality Management Systems (QMS)
Ability to lead test method validations and protocols
Proficiency in root cause analysis and CAPA activities
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Collaborative team player mindset
Key Requirements
Minimum Bachelor's degree in engineering
3+ years relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)