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
• Solid analytical and communication skills
Help redefine safety and quality in innovative medical solutions at Capgemini Engineering.
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