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Nuelle Inc is seeking a Principal Quality Engineer with over 10 years of experience in engineering roles to provide strategic quality guidance in the medical device sector. The ideal candidate will lead quality initiatives, ensure compliance with regulatory standards, and mentor junior engineers while upholding the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.
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Job Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer’s goals.
You will be recognized as a subject matter expert within Integer and challenged to solve unique and complex problems that have a broad impact on the business.
You may provide supervision for up to 4 to 5 engineering direct reports, and serve as a coach and mentor for other engineers.
Matching Summary
Match Score: 75
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Nuelle Inc is seeking a Principal Quality Engineer with over 10 years of experience in engineering roles to provide strategic quality guidance in the medical device sector. The ideal candidate will lead quality initiatives, ensure compliance with regulatory standards, and mentor junior engineers while upholding the company's core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.
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Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DMR)
Bill of Materials (BOMs)
FMEAs
Control Plans
Process validation
Test method validation
Non-conforming material disposition
Corrective and preventive actions (CAPA)
Nice-to-have
Subject matter expert
Global customer interaction
Continuous improvement leadership
Cross-functional team collaboration
Mentorship and coaching
Key Requirements
10+ years of progressive engineering experience
Bachelor's degree in engineering or related technical field
Awareness of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)