Quality Assurance Associate - (Co-op 8+… at FluidAI · Kitchener

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.