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Integer is seeking a NPI Quality Engineer III to apply advanced engineering principles to New Product Introduction projects while ensuring quality standards are met. The ideal candidate will have a strong technical background, leadership skills, and experience in quality management within regulated environments.
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Job Summary
The primary purpose of this role is to apply intensive knowledge of engineering principles to New Product Introduction projects while ensuring customer expectations are met.
Candidates will lead test method development, conduct validation studies including gage R&R, and support regulatory inspections and audits.
This position requires adherence to Integer's values and all safety, environmental, security, and quality requirements including FDA regulations.
Matching Summary
Match Score: 75
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Integer is seeking a NPI Quality Engineer III to apply advanced engineering principles to New Product Introduction projects while ensuring quality standards are met. The ideal candidate will have a strong technical background, leadership skills, and experience in quality management within regulated environments.
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Skills & Requirements
Must-have
Bachelor's degree in engineering
5+ years progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management
Experience with FDA regulations and QMS
Six Sigma Green Belt certification minimum
Nice-to-have
Black Belt Six Sigma certification preferred
Cross-functional team leadership experience
Positive can-do attitude under pressure
Continuous improvement project leadership
Ability to work independently on technical matters
Key Requirements
Bachelor's degree in engineering or related field
Minimum 5 years of progressive engineering experience
Six Sigma Green Belt certification required
Black Belt certification preferred
US citizenship or work authorization not explicitly stated