Sr. Software Quality Engineer

Job description

PURPOSE AND SCOPE: Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived PRINCIPAL DUTIES AND RESPONSIBILITIES: · Works as part of software development team on new product development or on design changes to ensure product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance. · Reviews and approves design control deliverables along the product development process as well as design changes · Partners with and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. · Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis while complying with the relevant standards · Responsible for the specification of risk reduction measures (requirement management) · Ensuring that all activities relating to risk management are c...