Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design-related activities during the software lifecycle.
Can lead quality-related problem-solving for software.
Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required.
Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards.
Requirements
Bachelor's degree in Engineering or Computer Science required
5 years relevant experience
Experience with JAMA, Jira, Confluence, CI/CD and DevOps, SAP, Agile tools such as: configuration management, source control, unit testing
Experience in Software Risk Management
Working knowledge of appropriate global regulations, requirements, and standards for SiMD & SaMD, including Machine Learning / Artificial Intelligence solutions.