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 support engineering methods and quality assurance in the medical device industry. The ideal candidate will possess a relevant engineering degree and experience, with a focus on regulatory compliance, quality management systems, and continuous improvement initiatives.
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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 develop your role as a quality engineer at Integer.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Quality Engineer II to support engineering methods and quality assurance in the medical device industry. The ideal candidate will possess a relevant engineering degree and experience, with a focus on regulatory compliance, quality management systems, and continuous improvement initiatives.
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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 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 with cross-functional experience
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, MDD)