Capgemini Senior Software Quality Engineer

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 innovative medical solutions at Capgemini Engineering. #J-18808-Ljbffr