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? 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.
Use a risk-based approach to quality. 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 and maintain process risk documentation in line with ISO 14971, and evaluate process risks to set appropriate controls throughout the product lifecycle
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
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.
Bachelor’s Degree in engineering or a science-related field.

- 2-5 years of experience working in a medical device or similarly regulated environment.
- Strong knowledge of Quality Concepts, with the judgement to know where requirements can flex and where they can't.
- Comfort making risk-based decisions with incomplete information, and the ability to clearly document and defend your rationale.
- Strong project management skills and the ability to juggle shifting priorities in a rapid-moving environment
- You help the team find practical, compliant solutions instead of simply flagging problems.
- Ability to work cross-functionally with departments such as Operations, Product Development, Regulatory Affairs, R&D;, and Marketing.
- Experience interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).

Experience preparing or supporting regulatory submissions
Experience interacting with regulators, notified bodies, auditing organizations, and testing laboratories
Thorough knowledge of Canadian, US, and International Medical Device Regulations
Experience assessing changes for regulatory reportability
Familiarity with post-market surveillance, complaint handling, and adverse event reporting
Familiarity with IEC 62304 and software as/in a medical device
Experience building or scaling a QMS at a startup or early-stage company
Familiarity with Six Sigma and/or Lean manufacturing.
Applied knowledge of Advanced Quality tools (FMEA, GD&T;, Root Cause Analysis, Mistake Proofing/Poka Yoke).
Experience with the medical device product development lifecycle (risk management, design/process verification,



and validation).
Ability to read and interpret CAD drawings.
Experience working in compliance risk situations.
Familiarity with Python or similar programming languages.
Salary range for this position is $70,000 - $85,000 CAD annually.
We do not use AI or AI-Augmented Applicant Tracking Systems (ATS) to screen, assess, reject, or select candidates.
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 opportunity 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.
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.

📌 MANUFACTURING ENGINEERING QUALITY ENGINEER H/F (Kitchener)
🏢 NERv Technology Inc. d.b.a. FluidAI Medical
📍 Kitchener