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*Title: Validation Tester* *Location : San Francisco, CA* *Duration : Long Term* *Max Rate $47/hr/c2c* Skills set: Medical Device Testing, 21 CFR Part 820 *Job Description:* • 8 - 10 years of experience in Medical device product verification, Regulatory compliance, Risk Management and SW Hazard analysis activities for Class I, II and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC 62304 and GAMP-5 Computer System Validation (CSV) • Experience in EU Medical Device regulations and CE marking process and related SOP creation • Experience in working with Notified bodies and work experience in handling ISO 13485, EU notified body audits • Experience in ensuring Design Control compliance and Design History file( DHF) maintenance • Expertise in Test Management, Design verification Strategy and Planning, test execution, Regression test strategy, Design verification summary report ,defect report documentations and onsite-offshore coordination • Developed the SOPs for Design Verification, Validation, Design Output activities in line with FDA medical device regulations and IEC 62304 Thanks, Ranjith Kumar 408-868-2905 ranjith.vem...@themesoft.com Themesoft INC -- You received this message because you are subscribed to the Google Groups "Oracle-HRMS-India" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracle-hrms-india+unsubscr...@googlegroups.com. To post to this group, send email to oracle-hrms-india@googlegroups.com. Visit this group at https://groups.google.com/group/oracle-hrms-india. For more options, visit https://groups.google.com/d/optout.
