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Principal Quality Engineer

Employer
EPM Scientific
Location
California, KY
Closing date
Sep 23, 2022

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The Principal Quality Engineer is responsible for ensuring combination products are developed in accordance with appropriate device regulations. Supporting design and development of products up until product transfer to manufacturing.

Responsibilities:

* Quality Representative on Design/Development and Manufacturing project teams
* Ensure Design Control Elements are satisfied
* Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
* Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

Education and Skills:

* 7+ years of Quality Engineering experience in a relevant industry (Healthcare/Pharma)
* Knowledgeable of industry regulations - ISO 14971, IEC62304, 21CFR820
* Understanding of Statistical Methods for Quality Assurance

Feel free to message Matthew Lindsay or call him at 312-896-0654
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