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 stages • Create and maintain documentation for traceability purposes • Lead risk management practices including FMEA • Review software development processes for regulatory compliance • Facilitate internal audits and support regulatory inspections
Requirements: • Bachelor’s degree in relevant technical field • Over 10 years’ experience in software quality assurance • Knowledge of FDA standards and quality regulations • Proven experience with risk management methodologies • Strong analytical and communication skills
Help redefine safety and quality in cutting-edge medical solutions at Capgemini Engineering. #J-18808-Ljbffr