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Please go through the below job description and let me know your interest for the below role. *Tester with Knowledge of testing medical products, Milwaukee WI* *Mandatory Technical Skills:* • Experience as a Verification and Validation Engineer for 5+ years • XRAY product testing experience [System Testing experience mandatory] • Strong knowledge of Microsoft Windows technologies • Strong belief in quality compliance and following rules • Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems • Knowledge of testing medical products • Knowledge of FDA regulations required to test medical products • Expertised in quality reviews *Desirable Technical Skills:* • Prepared, reviewed, executed and summarized validation protocols • Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention • Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control • Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing. • Experienced in testing Software, Web Applications, IVR, System Components, and Database • Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing. • Participated in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/ Protocols and signed off (Pass/Fail) • Participated in Requirements gathering, Code Reviews/ Walk Trough. • Hands-on experienced in Automated Test Tool –Mercury Win Runner, Load Runner and Test Director. • Created defect tracking (manual repository), maintained and updated defect statuses and timelines. • Exposure in Risk Assessment and Testing Methodologies. • Exposure to Protocol Creation, Execution –IQ, PQ • Complaints Investigation for Medical Device (CAPA) • Exposure in FDA Regulations – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11 and CFR Part 820, ISO 14971, Risk Assessment for Medical Device, ISO 1345, IEC 62304 – International Standards (Europe and US) • and IEEE, SEI, Six Sigma and other ISO standards and regulations. *Shivani Gaur* | SYSMIND, LLC [image: https://newoldstamp.com/editor/profilePictures/profile-b15c8fc3ea4630e2ca604f11e3e951c7-41898.png] *Technical Recruiter* Phone: 609-897-9670 x 2160 Email: shiva...@sysmind.com Website: sysmind.com Address: 38 Washington Road, Princeton Junction, NJ 08550 -- You received this message because you are subscribed to the Google Groups "USITCV" group. To unsubscribe from this group and stop receiving emails from it, send an email to usitcv+unsubscr...@googlegroups.com. To post to this group, send email to usitcv@googlegroups.com. Visit this group at https://groups.google.com/group/usitcv. For more options, visit https://groups.google.com/d/optout.
