*Skills Hihglighted in RED is Mandatory*

Job title:
*Quality engineer with Medical Device *

Location: Wayne, PA

Duration: 6-12 Months Contract



*Required Skills:*

Design Quality engineer with extensive experience in *Design Control*, *Risk
Management and Design Verification/ Validation of software medical devices*.

ISO 14971:2012, ISO 13485:2012, 21 CFR 820.30 (design control) and other
international standards.

working knowledge of *CAPA systems, Risk Analysis and DFMEA/PFMEA. *

Extensive experience in a *FDA* or other regulated environment.

Knowledge of Quality Center or equivalent tool is a plus.

Thanks and Regards
*Ethan Hunt*
*Agile Enterprise Solutions Inc*.
Phone: *630-242-8896 Ext:321* || Fax: 630-206-2397
E: *[email protected] <[email protected]>* ||
*http://www.aesinc.us.com
<http://www.aesinc.us.com>*

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