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Added 17 mins 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 17 mins ago
HT
PD Software for Service
Husky Technologies
Bolton, ON
- Full-time
The Service team is currently seeking a Software engineer/designer to specialize in resolving service issues with a focus on Injection Molding Machine controls, including servo drive and…
Added 17 mins ago
SH
Regional Clinical Engineer - Masters
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
…(Performance Verification, Preventive Maintenance and Safety Testing); risk management (medical device statutes and regulations; electrical safety; incident investigation; Recalls and…
Added 17 mins 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 17 mins ago
Regional Clinical Engineer - Masters
Winnipeg Regional Health Authority
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…(Performance Verification, Preventive Maintenance and Safety Testing); risk management (medical device statutes and regulations; electrical safety; incident investigation; Recalls and…
Added 32 mins ago
O
Finance Operations Analyst (EVC)
omnie
Canada
- Full-time
This role sits at the intersection of accounting operations and light data work. You don't need to be an engineer, but you do need to be comfortable living in Excel and Power Query, reading…
Added 47 mins ago
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Watchkeeping Engineer (Senior Engineer)
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- Full-time
Marine Atlantic is currently looking for a Watchkeeping Engineer (Senior Engineer) to work onboard our vessels that operate from the ports of Port aux Basques NL and North Sydney NS year…
Added 47 mins ago
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Analyste d’affaires – D365 Business Central (Secteur Manufacturier)
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- Full-time
Implement and configure the Quality Inspector application to structure quality checkpoints, receiving inspections, in-process testing, and non-conformance management
Added 1 hour ago
SA
Electrical Engineer
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Cambridge, ON
- Full-time
We are looking for a hands-on engineer with experience in electrical hardware, power electronics, controls, and embedded systems who can independently take projects from concept through…
Added 2 hours ago
EA
Controls & Field Service Technician
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- Full-time
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Added 2 hours ago
AC
D365 F&O Functional Analyst
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Richmond, BC
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Lead enhancements from requirements gathering through configuration, testing, and implementation.
Added 3 hours ago
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Optical Systems Validation Engineer
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Ottawa, ON
- Full-time
Experience with Python and GIT for the purpose of IC testing, automation, and software version control
Added 4 hours ago
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Engineer - Ground Control
Vale
Canada
- Full-time
We are currently seeking an Engineer, Geomechanics to join the Vale Base Metals CTO Geotechnical Office’s Geomechanics Studies team based in Sudbury, Ontario, Canada. This is a permanent…
Added 4 hours ago
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Building Code Consultant
QAI Laboratories
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- Full-time
Founded in 1995 by a group of experienced certification and testing experts, QAI is an independent third-party testing, inspection, and certification organization that serves the building,…
Added 4 hours ago
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Software Architect
trane technologies
Montreal, QC
- Full-time
…driving analytics for greater efficiency, your ideas will help engineer solutions for stronger communities and a sustainable…
Added 4 hours ago
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Full Stack Engineer
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Toronto, ON
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Job Title: Software Engineer – AI-Assisted Development
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Senior Salesforce Engineer
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- Full-time
We are seeking a hands-on Salesforce Platform and AI Engineer to design, build, and scale secure, data-driven solutions that advance CCS’s mission. This role combines Salesforce…
Added 5 hours ago
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Structural Analysis Engineer
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Richmond, BC
- $95,000 to $115,000 CAD / year
- Full-time
The Structural Mechanical Engineer / Stress Analyst will be responsible for the structural integrity and dynamic structural performance of large-scale machine systems, with a primary focus…
Added 5 hours ago
A
Senior Software Engineer
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Kitchener, ON
- Full-time
Aspiring IT Inc. is seeking an experienced Senior Software Engineer to design, develop, integrate, and maintain scalable software applications and cloud-based systems.
Added 5 hours ago
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Candidat à la profession d'ingénieur électrique systèmes auxiliaires – Hydro Amérique du Nord / Auxiliary Systems EIT Electrical Engineer – Hydro North America
GE Vernova
Brossard, QC
- Full-time
The Systems Engineer will be responsible for the integrated design, coordination, and technical support of both electrical and mechanical auxiliary systems associated with hydro-generator…
Added 5 hours ago
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Ingénieur de projet – Développement de produits pour véhicules connectés (Gestion technique de projets) / Project Engineer – Connected Vehicle Product Development (Technical Project Management)
Expleo
Valcourt, QC
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…www.expleogroup.com._________________________________________________________________________________________________________________________________________________________________________…
Added 5 hours ago
PH
Founding Engineer
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Remote, Canada
- $150,000 to $190,000 CAD / year
- Full-time
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As our first engineer, you'll work directly with the founder, a practising physician who built the platform, and with our clinical collaborators. You'll take ownership of a working system…
Added 5 hours ago
AC
Engineer, Project
AVI-SPL Canada
Montreal, QC
- Full-time
As a Project Engineer, you will oversee the technical delivery of AV Integration projects. You will review new projects, finalizing documentation such as the bill of materials, drawings,…
Added 5 hours ago
B
Senior Software Developer
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- Full-time
Lead the design, development, testing, and deployment of customer-impacting features
Added 5 hours ago
Engineer, Test Equipment
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Redlen is seeking a hands-on Engineer, Test Equipment to support the testing and validation of advanced photon-counting X-ray detector products in a high-volume manufacturing environment.…

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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