Senior Software Quality Engineer

Position: 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.
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