Immediate requirement for Verification & Validation Engineer at Milwaukee , Wisconsin
Hi, Hope you are doing great! USG direct client is looking for* Verification & Validation Engineer at **Milwaukee , Wisconsin* *Job Title:* *Verification & Validation Engineer* *Location: **Milwaukee , Wisconsin* *Position Type:** Contract* *Interview Type: Phone and Skype* *Mandatory Technical Skills:-* · 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 *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. *Mandatory Functional Skills:-* · Create and revise Design Verification and Validation (V) Procedures · Participate in Design Verification and Validation Procedure Reviews · Setup and configure Test Equipment · Perform dry runs and formal Verification and Validation (V) activities as required · Perform dry runs for formal Usability test activities as required · Perform remediations of V results as required · Record and close defects found during V activities · 8.Computer Software Validation (CSV) Test/ Protocol execution for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation (PQ) · Performed Dry run –Data Set Up (Role based), test script/ protocol execution for CAPA and Investigations, per Business, Functional Requirements and User Requirements and identify deviations (TDRs) – system, design, logic/ workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system that supports the Johnson & Johnson Group of Consumer Companies (JJGCC), providing CD (Consent Decree) computer validation technical consulting services for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation · Performed execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements. · 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 *Desirable Functional Skills:-* · Understanding of healthcare environment . *· *Experience in a medical device or
Immediate requirement for Verification & Validation Engineer at Milwaukee , Wisconsin
Hi, Hope you are doing great! USG direct client is looking for* Verification & Validation Engineer at **Milwaukee , Wisconsin* *Job Title:* *Verification & Validation Engineer* *Location: **Milwaukee , Wisconsin* *Position Type:** Contract* *Interview Type: Phone and Skype* *Mandatory Technical Skills:-* · 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 *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. *Mandatory Functional Skills:-* · Create and revise Design Verification and Validation (V) Procedures · Participate in Design Verification and Validation Procedure Reviews · Setup and configure Test Equipment · Perform dry runs and formal Verification and Validation (V) activities as required · Perform dry runs for formal Usability test activities as required · Perform remediations of V results as required · Record and close defects found during V activities · 8.Computer Software Validation (CSV) Test/ Protocol execution for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation (PQ) · Performed Dry run –Data Set Up (Role based), test script/ protocol execution for CAPA and Investigations, per Business, Functional Requirements and User Requirements and identify deviations (TDRs) – system, design, logic/ workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system that supports the Johnson & Johnson Group of Consumer Companies (JJGCC), providing CD (Consent Decree) computer validation technical consulting services for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation · Performed execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements. · 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 *Desirable Functional Skills:-* · Understanding of healthcare environment . *· *Experience in a medical device or
