*POSITION- Verification & Validation Engineer LOCATION-  Milwaukee ,
Wisconsin*

*Duration – 10 Months*


*• Experience as a Verification and Validation Engineer for 5+ years*

*• XRAY product testing experience*

*• Strong knowledge of Microsoft Windows technologies *

*• Excellent communication skills, written and verbal*

*• Detail oriented and meticulous worker *

*• Good organizational skills in recording test results *

*• 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*

*• 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).*









*Regards,*
*Atul Sharma*
IT -recruiter
a...@idctechnologies.com <ashw...@idctechnologies.com>
Direct: 408.418.5778 <(408)%20418-5778>  EXT 3027

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