Position Overview
Shape the future of medical technology at OrganOx as a Software Quality Engineer. This on-site role in Oxford emphasizes software quality assurance and regulatory compliance.
As a member of OrganOx's Quality team, you will support all aspects of software quality across the development lifecycle. Your proven expertise in medical device software will be key in conducting risk assessments and adhering to IEC 62304 standards. You'll collaborate with various teams to ensure that all software documentation meets the necessary regulatory requirements and helps improve patient outcomes.
Key Responsibilities:
β’ Validate software quality throughout development stages
β’ Create accurate documentation and test reports
β’ Participate in design reviews and risk assessments
β’ Conduct FMEA to preemptively address software risks
β’ Support quality initiatives in a collaborative environment
Requirements:
β’ Experience in regulated so...