FluidAI is specialized in the development and deployment of data-driven surgical solutions, with an initial focus on general and gastrointestinal surgery. Our technologies integrate medical devices, software, and artificial intelligence into platforms that address real clinical and operational challenges across the continuum of surgical care.

We combine continuous physiological monitoring from our proprietary sensors with comprehensive electronic health record data, creating intelligent systems that enable earlier identification of clinical deterioration and complications. Beyond patient monitoring, our platform extends to patient education and engagement tools, as well as automated documentation and coding modules — supporting care teams and driving operational efficiency.

Our team brings together expertise across clinical practice, research, engineering, data science, manufacturing, and commercialization. We build solutions designed for real-world impact, supported by full in-house capabilities, a strong intellectual property portfolio, and partnerships with leading institutions around the world.

We are an equal prospect employer and have a diverse team representation across language, ethnicity, gender and nationality.

Why Join FluidAI Medical?

- Mission to save lives and improve patient care with technology that’s already deployed on patients in real-world settings.
- Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
- Gain exposure across the entire technical stack, from novel sensing technologies and proprietary hardware to mobile/web software and ML algorithms.
- Personal career-focused development and training with access to workshops, coursework,



and experienced mentors/consultants.
- Regular offsite activities – past events include rafting, cottaging, axe-throwing, sports leagues, and the usual BBQ.

Job Summary:

Do you believe that quality and fast progress can go hand in hand? Do you enjoy solving technical problems in a fast-paced environment? Are you passionate about quality and delivering life-changing medical devices? If so, read on

At FluidAI, patient safety and regulatory compliance are non-negotiable. We rely on sound judgement and a risk-based approach to meet them effectively, focussing effort where it matters most. You’ll work closely with a cross-functional team to support the development, implementation, and operation of a Quality Management System that is compliant while also being clear, efficient, and scalable. You’ll make sure our controls fit the risk, keep documentation meaningful, and help the team efficiently meet requirements. You’ll also support regulatory activities across Canada, the US, and International markets.

This position requires you to come into our Kitchener, ON office at least 50% of the time.

Job Responsibilities:

- Use a risk-based approach to quality. Apply rigor where it matters most, and keep things lean where it doesn't.
- Partner with engineering and operations to ensure quality is built into product and processes




- Own the linkage of Design Controls in all stages of the production lifecycle.
- Ensure product, material, and process specifications are clear, unambiguous, and practical for production.
- Create test methods and strategies for existing and new products, backed by sound statistical rationale.
- Plan, execute, and analyze test method/process validations.
- Lead and support component/product inspection and qualification activities.
- Support identification, auditing, and onboarding of new suppliers to ensure compliance and business continuity.
- Create and maintain process risk documentation in line with ISO 14971, and evaluate process risks to set appropriate controls throughout the product lifecycle
- Lead investigation and timely closure of non-conformances and CAPAs.
- Assess engineering change for quality and regulatory impact, and maintain change control in a way that keeps work moving.
- Support regulatory submissions, licence applications and amendments, and responses to regulator questions.
- Support post-market activities, including complain handling, post-launch monitoring, and trend analysis.
- Support the creation of Device Master Records and the transfer of processes to manufacturing
- Support internal audits, external audits (ex: MDSAP), and interaction with testing laboratories
- Look for ways to simplify and improve the QMS, and challenge processes that add burden without reducing risk
- Collaborate with Subject Matter Experts on process validation activities to ensure consistent, repeatable, and effective processes are implemented during design and manufacturing transfer.
- Maintain and support the development of process contr

📌 Quality Engineer (Kitchener)
🏢 FluidAI Medical
📍 Kitchener