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
atul@idctechnologies.com
Direct: 408.418.5778 EXT 3027
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