Senior Quality System Associate at Celestra Health

Celestra Health Systems is hiring a Senior Quality System Associate based in Ottawa. Focus on regulatory compliance and quality management for cutting-edge software medical devices.
This role requires you to support the QMS implementation while coordinating regulatory submissions and preparing necessary documentation for EU MDR and FDA compliance. You will work closely with external consultants and internal teams to ensure our products meet all regulatory requirements. Driving improvements in quality processes, you will play a pivotal role in our growth as a software solution provider in the medical field.
Key Responsibilities:
• Lead implementation of the Quality Management System
• Prepare technical documentation for regulatory approval
• Support cross-functional teams during quality audits
• Maintain training records and CAPA processes
• Respond to regulatory queries and facilitate inspections
Requirements:
• Bachelor's degree in Quality Systems or Life Sc...