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The Integer Group is seeking a Quality Engineer II with a focus on ensuring compliance with quality management systems and regulatory standards within the medical device industry. The role involves utilizing advanced quality tools, collaborating with cross-functional teams, and contributing to continuous improvement initiatives to enhance product 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 support regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
You are expected to lead the generation and completion of protocols and reports for test method validations and coordinate process validations.
Matching Summary
Match Score: 75
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The Integer Group is seeking a Quality Engineer II with a focus on ensuring compliance with quality management systems and regulatory standards within the medical device industry. The role involves utilizing advanced quality tools, collaborating with cross-functional teams, and contributing to continuous improvement initiatives to enhance product quality.
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Skills & Requirements
Must-have
Bachelor's degree in engineering
3 years relevant experience
Knowledge of ISO and QSR regulations
Experience with FDA regulations
Root cause analysis skills
CAPA process management
Nice-to-have
Continuous improvement mindset
Strong written and oral communication
Ability to work independently
Positive can-do attitude
Collaborative team player
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)