*Job title: Validation Engineer with Medical Devices* *Location: Irvine, CA*
*Duration: 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>* || *http://www.aesinc.us.com <http://www.aesinc.us.com>* -- -- To unsubscribe from this group, send email to cbe-software-engineer-unsubscr...@googlegroups.com For more options, visit this group at http://groups.google.com/group/CBE-Software-Engineer?hl=en --- You received this message because you are subscribed to the Google Groups "CBE Software Engineer" group. To unsubscribe from this group and stop receiving emails from it, send an email to cbe-software-engineer+unsubscr...@googlegroups.com. For more options, visit https://groups.google.com/d/optout.
