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, ensuring adherence to quality standards and regulations. The ideal candidate will possess a bachelor's degree in engineering or a related field, with at least three years of relevant experience, and demonstrate strong problem-solving and communication skills.
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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 and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
You are expected to collaborate with others, ask questions, and regularly check for understanding to support your development as an engineer.
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, ensuring adherence to quality standards and regulations. The ideal candidate will possess a bachelor's degree in engineering or a related field, with at least three years of relevant experience, and demonstrate strong problem-solving and communication skills.
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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 CAPA investigations and root cause analysis
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Collaborative team player with cross-functional experience
Proficiency in Microsoft Office tools
Experience with continuous improvement methodologies
Key Requirements
Bachelor's degree in engineering
3+ years relevant experience
Awareness of domestic and international regulations