Join Capgemini Engineering as a Senior Design Quality Engineer and ensure compliance in medical device development. This hybrid role focuses on safeguarding end-to-end design quality of Class II/III devices.

As a Senior Quality Engineer, you will be essential in managing design quality and ensuring adherence to industry regulations. Your expertise will cover risk management and software lifecycle compliance, working with interdisciplinary teams. You'll lead efforts in improving processes while supporting regulatory audits and submissions.

Key Responsibilities:
• Validate design controls ensuring compliance with standards
• Maintain comprehensive documentation for traceability
• Conduct risk analysis and integrate controls into designs




• Guide software verification activities across SDLC processes
• Support regulatory submissions and institutional audits

Requirements:
• Bachelor's degree in Engineering or related discipline
• 10+ years in software quality assurance, ideally in medical devices
• Proficient in FDA regulations and standards
• Strong background in risk management and design controls
• Excellent documentation and stakeholder communication skills

Contribute to the success of cutting-edge medical devices through your quality assurance expertise at Capgemini Engineering.
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📌 Senior Quality Engineer for Medical Devices (Ontario)
🏢 Capgemini
📍 Ontario