*Send Resumes to ethan_h...@aesinc.us.com <ethan_h...@aesinc.us.com>*



*Job title: Validation Engineer with Manufacturing OR Medical
DevicesLocation: Irvine, CADuration: 6+ Months Contract*

*Required Skills:*
Experience in LEIs  and CSV validation
Experience in Medical device Verification and Validation
Experience in FDA
5 -7 years of experience in Tool validation

*Responsible for the following:*
Intended use collection as part of Quality and Regulatory Assessment
21 CFR Part 11 coverage Assessment and  21 CFR Part 11 compliance
Assessment
Risk Assessment
User Requirement specifications for the intended use.
Requirement Traceability Matrix
Qualification Plan
Creation of Test cases in Quality Center for Installation Qualification,
Operational Qualification and Performance QualificationTest execution of
Installation Qualification, Operational Qualification and Performance
Qualification in Quality center
Qualification Report.
SOP preparation.

Thanks and Regards
*Ethan Hunt*
*Agile Enterprise Solutions Inc*.
Phone: *630-242-8896 Ext:321* || Fax: 630-206-2397
E:
*​​ethan_h...@aesinc.us.com <ethan_h...@aesinc.us.com>* ||
​ *Gtalk*:* ethan.catt...@gmail.com <ethan.catt...@gmail.com>* ​

 *http://www.aesinc.us.com <http://www.aesinc.us.com>*

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