Quality Assurance Associate - (Co-op 8+ Months Preferred) in Kitchener, Ontario at NERv Technology Inc. D.B.A. FluidAI Medical

Company Description:

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 teams 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.

Why join FluidAI?

• 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.

Job Summary:

We're hiring a Quality Assurance Co-op to join our QA team and support the day-to-day operation of our ISO 13485-compliant quality management system. This is a generalist role designed to give you broad exposure to MedTech quality — investigations, audits, document control, training, design and change control, and data analysis — inside a real, regulated environment.

You'll work alongside our QA team and partner closely with manufacturing, R&D, and regulatory affairs. By the end of the work term, you'll have a strong foundation across the QA discipline and a clearer sense of which corner of it you want to grow into.

Job Responsibilities:

• Support non-conformance (NCR) and CAPA investigations, including root cause analysis and effectiveness checks.
• Assist with internal audits and external audit preparation (MDSAP, ISO 13485, Health Canada CMDR, FDA 21 CFR Part 820/QMSR).
• Administer the eQMS day-to-day: assign and track training, manage records, follow up on overdue items.
• Support change control and design control activities (ECOs, design history file maintenance, traceability).
• Pull, clean, and analyze quality data to surface trends across NCRs, complaints, and audits.
• Help develop and improve SOPs and work instructions.
• Document everything in accordance with ISO 13485:2016 and applicable regulatory requirements.
• Contribute to process improvement projects across QA, manufacturing, and R&D.

Qualifications:

These are some of the skills we are looking for in an ideal candidate. If you check some but not all of these boxes, please apply anyway!

• Working towards a technical degree (engineering, sciences, etc.)
• Strong attention to detail.
• Clear, professional written communication.
• Comfortable with AI tools to support day-to-day work and quick to pick up new tools.
• Solid grounding in foundational stats and experimental design.
• Curiosity about regulator environments and a willingness to ask “why” before jumping to “how”.
• Python for data analysis.

Bonus Qualifications:

• Prior experience in medical devices, pharma, or other regulated industries.
• Exposure to ISO 13485, 9001.
• Familiarity with Atlassian tools.
• Familiarity with root cause analysis methods.

Transparency & Hiring Practices:

• Compensation: The pay for this position will be based on average co-op wages as outlined by your academic institution’s co-op program or similar institutions if specific data is unavailable, ensuring fair and competitive compensation aligned with industry and academic standards.  The typical range for this role is $22 - $25 per hour for work terms 2-4.

• Grant Eligibility: This position is made possible through wage subsidy grants such as BioTalent SWPP. As such, participants must be a current full-time student registered in a Canadian Post-secondary program. International students are not eligible. Eligible participants must be a Canadian citizen, permanent resident or person who has been granted refugee status in Canada and be legally entitled to work.
• Application Screening: All applications are screened manually. We do not use AI or AI-Augmented Applicant Tracking Systems (ATS) to screen, assess, reject, or select candidates.
• Position Status: This fall term position will become available in September 2026.