Job Description :
Mandatory Technical Skills:
BSEE/BSCS or equivalent Technical Degree
Experience as a Verification and Validation Engineer for 5+ years
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

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.
Hands on use of ETQ, Documentum, Trackwise ,LIMS ePAS, DMS (Data Management System), EDMS, Citrix, AMM (AS/400), Citrix and Cognos, HL7 – Logix OE, Logix OE, Documentum.

Desirable Functional Skills:
Understanding of healthcare environment .Experience in a medical device or pharmaceutical industry testing. Quality reviewer in verification and validation.

Client : IT services, consulting and business solutions organization that delivers real results to global business