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Added 11 mins ago
MD
Construction Project Operations Manager
Minnesota Direct Care and Treatment
Saint-Paul, NB · St.-Paul, NB
- Full-time
…Office products, construction project management, or similar product(s) to communicate, generate and analyze reports, and track/monitor project…
Added 11 mins ago
GD
Computer Modeling & Simulation Staff Specialist/Engineer
General Dynamics Land Systems–Canada
London, ON
- Full-time
Computer Modeling & Simulation Staff Specialist/Engineer P55
Added 11 mins ago
P
Product Engineer, Mobile & UX
Pontosense
Toronto, ON
- Full-time
We're looking for a Product Engineer who loves building great software, cares about how people experience it, and is excited to push the boundaries of what's possible with AI. You'll work…
Added 11 mins ago
MA
Software Engineer
Milya AI
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Role Description The Software Engineer will be a full-time, on-site team member based in the Greater Montreal Metropolitan Area, contributing directly to the development of Milya’s…
Added 11 mins ago
SA
Engineering Manager - Production & Energy
Standard Aero
Winnipeg, MB
- Full-time
Lead engineering initiatives focused on improving production efficiency, reducing turnaround times, minimizing costs, and enhancing product quality.
Added 40 mins ago
ZF
Senior Infosec Engineer
Zerodha Fund House
NS · Richmond Road, NS
- Full-time
…investors. We think the mutual fund needs to be re-imagined as a product: simple, transparent, and relevant enough to bring the next 10 crore Indians into the capital markets. We are…
Added 1 hour ago
HT
Manufacturing Engineer (Contract)
Husky Technologies
Bolton, ON
- Full-time
We have an opening for a Mechanical / Manufacturing Engineer working with our Manufacturing Engineering Team as outlined below:
Added 1 hour ago
HT
PD Software for Service
Husky Technologies
Bolton, ON
- Full-time
…resolving systemic service issues. The team is responsible for all product lines (Machines, Molds, 3rd Party Hot runners, Controllers, and Auxiliaries) and works cohesively with a variety…
Added 1 hour ago
GI
Millwork Engineer / CNC Programmer
Giffin Interior
Engineer, BC
- Full-time
A Millwork Engineer at Giffin Interior transforms approved shop drawings into accurate engineering models, CNC programs & Saw patterns, and complete production documents. This role combines…
Added 3 hours ago
PS
SMTS 2
Platform9 Systems
Canada
- Full-time
We are seeking an experienced Software Engineer to join our team working on our cloud native product suite. The ideal candidate will have a strong background in computer science, have…
Added 4 hours ago
C-
Technical Sales and Field Service Engineer
Captiveaire - Region 114 Western PA
Ottawa, ON
- Full-time
Seeking a driven and motivated engineer to join our sales team focusing on growing business with existing customers and developing new business. This position will involve applications…
Added 5 hours ago
A
Forward Deployed AI Engineer - Senior Manager
Accenture
Calgary, AB · Vancouver, BC · Ottawa, ON · Toronto, ON
- Full-time
This is not a consulting role. It is not a project delivery role. It is not a research position. A Forward Deployed AI Engineer is a production engineer who works embedded inside a client's…
Added 5 hours ago
TT
Developer – Large Audio Language Models (LALMs) & End-to-End Speech-to-Speech Systems
TOSAN TECHNO | توسنتکنو
Toronto, ON
- Full-time
We are seeking a highly skilled and motivated AI Engineer to design, develop, and deploy advanced solutions using Large Audio Language Models (LALMs) and end-to-end Speech-to-Speech (S2S)…
Added 6 hours ago
WI
Computing Science Lecturer
Women In Machine Learning And Data Science, Mumbai
Burnaby, BC
- Full-time
Added 7 hours ago
HT
Manufacturing Engineer (Contract)
Husky Technologies
Bolton, ON
- Full-time
We have an opening for a Mechanical / Manufacturing Engineer working with our Manufacturing Engineering Team as outlined below:
Added 7 hours ago
HT
PD Software for Service
Husky Technologies
Bolton, ON
- Full-time
…resolving systemic service issues. The team is responsible for all product lines (Machines, Molds, 3rd Party Hot runners, Controllers, and Auxiliaries) and works cohesively with a variety…
Added 7 hours ago
L
AI/ML Engineer
lululemon
Vancouver, BC
- Full-time
As an AI/ML Engineer, you will contribute to the design and implementation of AI/ML systems across the full model lifecycle from dataset curation, feature engineering, and model training…
Added 7 hours ago
SA
Electrical Engineer
Smarter Alloys
Cambridge, ON
- Full-time
As our new Electrical Engineer, you will design, build, and test electrical and electromechanical systems for our Extract Energy heat-to-power technology and other innovative products…
Added 8 hours ago
I
Process/Project Engineer
Innophos
Port Maitland, ON
- $90,000 to $105,000 CAD / year
- Full-time
The Process/Project Engineer is primarily responsible for project development, estimation, planning, and execution. In addition, they are responsible for conducting engineering studies…
Added 8 hours ago
W
Continuous Improvement Engineer
Wonderbrands
Toronto, ON · Greater Toronto Area, ON
- Other
Reporting to the Continuous Improvement Leader, the Continuous Improvement Engineer will work on continuous improvement projects related to continually reducing costs and increasing overall…
Added 8 hours ago
Senior Project Engineer - Engineering
Give and Go Prepared Foods
Toronto, ON
…needed to support a wide range of projects across the areas of Product Development, Continuous Improvement and Asset…
Added 9 hours ago
AH
Device Design Engineer
Avalon Holographics
AB · Edmonton, AB
- Full-time
As we advance our display technology, we’re seeking a Device Design Engineer to help design and optimize the thin-film transistor (TFT) pixel and panel architectures at the core of our…
Added 9 hours ago
GA
Solutions Engineer Intern
Geekplus America Inc
Markham, ON
- Internship
Coordinate with Solutions Engineering, Sales, Project Management, Product, and other technical teams.
Added 10 hours ago
AM
Civil Project Engineer
Aplin Martin
Nanaimo, BC
- Full-time
The Project Engineer primarily serves as the Engineer-of-Record on projects they are assigned. On some projects they may perform a role of project leader and on others work more…
Added 11 hours ago
QL
Building Code Consultant
QAI Laboratories
Burnaby, BC
- Full-time
Review building codes to identify building product requirements, write test plans, evaluate construction products to code requirements, and write concise evaluation reports.

FluidAI Medical

Quality Engineer

Kitchener, ON, Canada

$70,000 to $85,000 CAD / year

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Job details

Pay: $70,000 to $85,000 CAD / year
Experience: 2-5 years of experience working in a medical device or similarly regulated environment.
Posting language: English
Posted: Nov 3, 2026

Original job description

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 control and monitoring to ensure effective process transfer activities and compliance

Required Qualifications:

Bachelor’s Degree in engineering or a science-related field.
2-5 years of experience working in a medical device or similarly regulated environment.
Working knowledge of ISO13485:2016, ISO 14971, IEC 60601-1:2005, and other relevant standards.
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 analytical skills with practical knowledge of statistical methods.
Strong project management skills and the ability to juggle shifting priorities in a fast-moving environment
Ability to work independently and take ownership.
Collaborative, solutions-oriented mindset. 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.
Strong interpersonal, written, oral communication, and negotiation skills.
Familiarity with cGMP.
Experience interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).

Preferred Qualifications:

MASc or MS.
CQE, CRE, or RAC certifications.
Experience preparing or supporting regulatory submissions
Experience interacting with regulators, notified bodies, auditing organizations, and testing laboratories
Experience with MDSAP audits
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.

Transparency & Hiring Practices:

Compensation: Salary range for this position is $70,000 - $85,000 CAD annually.
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 job posting is for an active vacancy.

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More about this job

Responsibilities

Develop, maintain, and improve a risk-based Quality Management System while ensuring design controls, specifications, validations, supplier quality, and manufacturing processes meet applicable requirements. Lead quality investigations and change control, support regulatory submissions and post-market activities, and contribute to audits and process transfers.

Requirements

Requires a bachelor’s degree in engineering or a science-related field and 2–5 years of experience in medical devices or a similarly regulated environment. Candidates should know ISO 13485, ISO 14971, IEC 60601-1, cGMP, and statistical methods, and be able to make risk-based decisions, manage priorities, and collaborate across functions.

Skills

Risk-Based Quality Management
Design Controls
Quality Management Systems
Process Validation
Statistical Analysis
Supplier Auditing
Risk Management
CAPA
Non-Conformance Investigation
Change Control
Regulatory Submissions
Post-Market Surveillance
Complaint Handling
Internal and External Auditing
Cross-Functional Collaboration
Project Management

Visa sponsorship

Not detected in the job text

Keywords

ISO 13485:2016
ISO 14971
IEC 60601-1
IEC 62304
cGMP
MDSAP
FDA
Health Canada
Quality Management System
Design Controls
Risk Management
FMEA
CAPA
Root Cause Analysis
Process Validation
Test Method Validation
Statistical Methods
Supplier Auditing
Change Control
Regulatory Submissions
Post-Market Surveillance
Complaint Handling
Adverse Event Reporting
Six Sigma
Lean Manufacturing
GD&T
Poka Yoke
Device Master Records
Medical Device Regulations
Python

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