Description

* 5+ years of product software experience in Medical devices domain * Experience in drafting Software based QMS procedures & work instructions (including third party softwares). * Strong knowledge of SDLC, software quality, and quality management systems. * Experience working in Agile/Scrum environments and knowledge of SDLC methodologies * Lead quality engineering activities, including Software risk assessments (RMF, FMEA, Cybersecurity) and Quality plan execution. * Manage CAPA investigations, root cause analysis, corrective actions, and effectiveness monitoring. * Review and approve requirements, design documents, test protocols, test results, and change requests

Key Skills

Education

Bachelor's degree