As Senior Design Quality Engineer, you will lead and support Quality activities for R&D, including medical device software development, in accordance with current standards, regulatory requirements and company procedures. You will ensure compliance, product safety and product performance in line with approved specifications, and act as the Quality partner and design control authority for R&D project teams.The role operates in accordance with the Insightec Quality Policy, relevant Quality Procedures and Standards, and privacy and safety rules.What you will be doing:· Lead and support design control activities for R&D projects, with focus on software development projects, from Design Planning through Transfer to Production· Ensure proper execution of design input, design output, verification and validation stages, including software requirements, architecture, verification and validation, and traceability· Review and approve R&D and technical documentation, including procedures, protocols and reports, with emphasis on software lifecycle deliverables· Provide Quality support of software development lifecycle processes in accordance with IEC 62304, including software classification, risk management, anomaly handling, configuration management and release· Provide Quality support for the validation of software tools used in the QMS and in R&D, including those used for development, testing, requirements and traceability management, and electronic QMS, in accordance with ISO 13485 and FDA guidance· Ensure usability engineering, cybersecurity and software risk management activities are integrated into design controls and risk management files· Support change control for R&D-related products and Life Cycle Management products, including software changes and releases· Review and approve Quality-related procedures and documentation· Support annual quality plan activities, Management Review, quality metrics and QA compliance KPIs· Lead internal audits and participate in external audits· Supporting the Complaints handling process activities as the design control point of contact· Operate within the framework of medical devices industry standards such as ISO 13485, FDA 21 CFR 820 (QMSR), MDSAP, EU MDR, ISO 14971 and IEC 62304.