Capgemini Engineering is looking for a Senior Design Quality Engineer with expertise in medical devices. Ensure regulatory compliance and high design quality for Class II/III devices in a hybrid setting.In this pivotal role, you'll oversee the design integrity and compliance of medical devices throughout all phases of product development. You'll engage with cross-functional teams to implement rigorous quality management practices, enhancing both workflow and adherence to standards. Your responsibilities will also extend to conducting audits and managing risk assessments.Key Responsibilities:Ensure fidelity to design controls across all development stagesCreate and maintain documentation for traceability purposesLead risk management practices including FMEAReview software development processes for regulatory complianceFacilitate internal audits and support regulatory inspectionsRequirements:Bachelor's degree in relevant technical fieldOver 10 years' experience in software quality assuranceKnowledge of FDA standards and quality regulationsProven experience with risk management methodologiesStrong analytical and communication skillsHelp redefine safety and quality in creative medical solutions at Capgemini Engineering.

📌 Capgemini Senior Software Quality Engineer (Burlington)
🏢 Capgemini
📍 Burlington