Role : Verification & Validation Engineer
Work Location : Milwaukee, WI
Duration of assignment (in Months) : 12+ months
Rate: $35/hr
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
• Expertise 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
1. Create and revise Design Verification and Validation (V&V) Procedures
2. Participate in Design Verification and Validation Procedure Reviews
3. Setup and configure Test Equipment
4. Perform dry runs and formal Verification and Validation (V&V) activities as required
5. Perform dry runs for formal Usability test activities as required
6. Perform remediations of V&V results as required
7. Record and close defects found during V&V activities
8.Computer Software Validation (CSV) Test/ Protocol execution for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation (PQ)
9. 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
10. 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 pharmaceutical industry testing. Quality reviewer in verification and validation.
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