CSV Engineer

CSV/Quality EngineerSeeking a CSV/Quality Engineer to join our client, a global leader in the medical device industry, working in Jacksonville, FL.The Quality Engineer will provide quality leadership on new product project teams to ensure that medical devices and stand-alone software systems are being designed and validated to meet their intended use. As a Quality Engineer, you will be subject matter expertise in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.Responsibilities:Support the design, development and testing of new medical devices. These devices are electro-mechanical systems that are operated by software.Ensure that project teams follow the New Product Development processes that pertain to software development.Partner with Metrology to refine requirements, and to ensure that architecture/ design documents are comprehensive.Facilitate the documentation and tracking of Code Review findings.Facilitate software risk assessment sessions and own the development of risk documents.Create/review/approve Test Protocols pertinent to system testing.Review test case execution results and manage defects.Own Non-conformances or CAPAs and drive root cause investigations.Perform other related duties as assigned by management.Proactively examine processes to identify areas for review, change, or elimination.Qualifications:A minimum of a Bachelors degree in Computer Science, Life Sciences, Engineering or related discipline with at least with 5 years of relevant experience is requiredExperience supporting the testing of electro-mechanical systems that are controlled by software is required.Excellent understanding of requirements management, configuration management, Software V&V, automated testing, defect management and software risk analysis is requiredExperience in the Medical Device or Pharma/Life Sciences industry is necessaryExcellent interpersonal skills and teamworkMust have the ability to solicit and document system requirements, and understand system architecture and software designs is preferredMust have had the experience designing test strategies based on software architecture, requirements and design is requiredKnowledge of ISO 14971, 21 CFR 820, and 21 CFR 210 and 211 is required.