Medical device quality engineering at FluidAI combines risk-based decisions, regulatory compliance, and practical controls in Kitchener, Ontario. Work from the office at least 50% of the time.

As a Quality Engineer, you will support FluidAI’s Quality Management System across development, manufacturing, and post-market activities. The position connects engineering, operations, regulatory affairs, research and development, and marketing. You will apply ISO 13485, ISO 14971, statistical methods, and design controls while supporting surgical technologies that integrate medical devices, software, and artificial intelligence.

Key Responsibilities:

- Partner with engineering and operations to build quality into products and processes
- Maintain process risk documentation aligned with ISO 14971
- Create test strategies and execute validation activities




- Lead non-conformance and CAPA investigations through timely closure
- Support regulatory submissions, audits, and post-market activities

Requirements:

- Bachelor’s degree in engineering or a science-related field
- Two to five years in medical devices or regulated environments
- Working knowledge of ISO 13485, ISO 14971, and IEC 60601-1
- Solid analytical, statistical, project management, and communication skills
- Ability to work independently and make risk-based decisions

Apply quality engineering, risk management, validation, and regulatory expertise to FluidAI’s surgical medical device platforms.

📌 Medical Device Quality Engineer (Kitchener)
🏢 FluidAI Medical
📍 Kitchener