Maintain and map the communication between systems, data sources and other aspects of the enterprise software system. Be the system expert on identifying and assessing system risks between large enterprise systems. Communicate to small teams, peers, and management. Provides guidance and support with technical solutions affecting and defining the Quality Management System. Supports new regulation gap analysis and updates to the Quality Management System. Support IT enterprise systems infrastructure, complex IT systems, implementation, deployment, post improvements, and maintenance. Ensure compliance for Domestic and International quality management systems. Supports continuous improvement and review of the Quality Management System. Approves and reviews complex system test case scripts, automation scripts, approvals, and validation support. Create engineering deployment and network diagrams for the system and applications. Provides guidance on data migration planning, scripting, and reporting. Works closely with IT and Quality to ensure compliance with numerous agencies and requirements This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Experience in software non medical device regulations (CFR Part 820, CSA, Validation for Non Product Systems, ISO guidance and regulations) Direct experience with Quality Management Systems, Enterprise Computer Systems risk management and validations preferred. Collaborative, able to work effectively with diverse functional groups. To perform this job successfully, an individual must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility. Experience creating user needs and requirements. Experience understanding and reading, at a minimum one scripting language. Must have an intermediate to advanced experience with performing verification and validation activities. Experience creating and understanding workflow and deployment diagrams. Experience working in a Quality capacity on large multi-layered Enterprise level systems.
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