Software Quality Assurance

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Responsible for assessing the quality of Abbott's software development process, and products developed by Abbott Hematology or purchased for use by Abbott Hematology customers. Will perform software audits and assessments to establish process effectiveness and conformance to Abbott internal and external regulatory requirements. Must be able to provide guidance to software teams in creating software project plans, processes, and procedures where appropriate, support nonconformance/problem reporting activities, support medical device product and nonproduct software development and validation efforts, assess project performance against plans, processes, and practices to determine project compliance and assist project management in formulating corrective or preventive action plans where necessary, and track to completion. Assure software requirements traceability from design through test and provide or review software certification documentation for 510(k) submissions. Support and participate in FDA, ISO, Corporate, Divisional, and Internal audits. This is a process-oriented function; NOT a software development or software testing position.QualificationsMinimum 5+ years experience in systems engineering, software development, software configuration management, software verification and validation, or directly relevant technical experience to demonstrate knowledge associated with degree and experience required. Must have excellent communication, presentation, leadership, and negotiation skills. Knowledge of regulations and standards ( FDA and ISO) affecting IVDs and Biologics and experience in a regulated environment are desirable. Bachelors, preferably Computer Science, Computer Engineering and/or related technical discipline.Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.