* Mandatory skills in RED what we need and Its come in QA*


*Job title:  QA Validation engineer with Medical DeviceLocation: Irvine,
CADuration: 6-12 Months Contract*

*Required Skills:*
*Engineer with electrical / electronic education background. *
*System engineering knowledge* – preferably from *product manufacturing *
background.
*Verification and validation skills*
Experience in *LEIs(Lab Equipment*)  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: *[email protected] <[email protected]>* ||
*http://www.aesinc.us.com
<http://www.aesinc.us.com>*

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