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Principal Quality Engineer

EPM Scientific
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.


* 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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