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Added 19 mins ago
SM
RQ11673 – Report Developer – Junior
S M Software Solutions Inc
Toronto, ON
- Internship
We are seeking a Junior Report Developer / Data Engineer with experience in developing, implementing, and maintaining enterprise data solutions using modern Azure cloud technologies. The…
Added 50 mins ago
E
Quality Engineer - Banking Mobile (iOS/Android) & Automation Testing
Experis
Toronto, ON
- Contract
We are seeking a results-driven Quality Engineer with extensive experience in mobile and digital banking platforms. The ideal candidate will play a pivotal role in building quality into…
Added 2 hours ago
A
Design Engineer, North America AMZL Design Engineering
Amazon
St. Thomas, ON
- Full-time
Our Operation’s workflow has three major components: First mile - where the product is housed and ready for order; Middle mile - where the order is hauled to your area; and Last mile - when…
Added 2 hours ago
I
Senior Product Manager - QuickBooks Workforce Solutions Mid Market
Intuit
Toronto, ON
- Full-time
…payroll, accounting, and money-movement domains. You define clear product requirements and success metrics, break down ambiguous problems into well-scoped features, and hold a high bar for…
Added 3 hours ago
Supplier Quality Engineer
Westerkirk
Calgary, AB
The Supplier Quality Engineer reports to the Director of Quality for Manufacturing and the primary purpose of the role is to; develop, implement, and coordinate the supplier approval…
Added 6 hours ago
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Senior Instrumentation & Controls Engineer 1 - Nuclear
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Toronto, ON · North York, ON
- Full-time
Prepare instrument data sheets (IDS) and instrument calibration sheets (IDS)
Added 6 hours ago
FT
AI Field Engineer, EMEA
FDE Times
London, ON
- Full-time
…to build, train, and serve AI models tailored to their own data, workflows, and products. Founded by the team behind PyTorch and backed by AMD, Atreides, Benchmark Capital, Index Ventures,…
Added 6 hours ago
FT
Agent Deployment Engineer - Spanish Speaking
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Toronto, ON
- Full-time
As an Agent Deployment Engineer, you will be responsible for end-to-end execution of AI agent builds for strategic customers. This is a highly technical delivery role where you will own the…
Added 6 hours ago
FT
ML Engineer Manager, AI Conversation Platform
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Toronto, ON · Greater Toronto Area, Canada
- Full-time
Brainstorm and coordinate product integrations with partner teams
Added 6 hours ago
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Agent Deployment Engineer
FDE Times
Toronto, ON
- Full-time
As an Agent Deployment Engineer, you will be responsible for end-to-end execution of AI agent builds for strategic customers. This is a highly technical delivery role where you will own the…
Added 7 hours ago
Software Dev Engineer II, Amazon Marketing Cloud
Amazon
Toronto, ON
…domains (massive scale streaming systems, machine learning, data science, cloud native development). We build front-ends in ReactJS and back-ends with Kotlin and native AWS. We are *not*…
Added 8 hours ago
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AI Software Development Engineer in Test
Trimble Inc.
Kamloops, BC
- Full-time
Shape the Future of Construction AI as an AI Software Developer Engineer in Test!
Added 8 hours ago
BE
MPD Technology - Automation Manager
Beyond Energy Services and Technology Corp.
Calgary, AB
- Full-time
Integrate third-party equipment and data: Coriolis meters, pressure transmitters, rig EDR/WITS/WITSML, hydraulics models and remote monitoring.
Added 10 hours ago
A
Test Engineer
Actalent
Ottawa, ON
- $50 to $60 CAD / hour
- Contract
The Test Engineer supports new product introduction and manufacturing test for fiber optic la equipment. This role sits alongside R&D while owning manufacturing-focused test activities…
Added 10 hours ago
Machine Learning Engineer, Evaluation and Quality, Creativity Apps
Apple
Vancouver, BC
The Creativity Apps team is looking for a Machine Learning Engineer focused on the quality and evaluation of ML models and AI features in our creativity applications. You will define how we…
Added 10 hours ago
Développeur.se de logiciels sénior.e - applications réseau / Senior Software Developer - Networking
Electronic Arts
Vancouver, BC · Montreal, QC
…and contribute to our experiences, supported by thoughtful product design, safety systems, and global reach. Our focus is on enabling more players to participate in creative expression by…
Added 12 hours ago
SM
RQ11673 – Report Developer – Junior
S M Software Solutions Inc
Toronto, ON
- Internship
We are seeking a Junior Report Developer / Data Engineer with experience in developing, implementing, and maintaining enterprise data solutions using modern Azure cloud technologies. The…
Added 13 hours ago
M
Senior Critical Environment Mechanical Engineer
Microsoft
Toronto, ON
- Full-time
Writes customized reports and functional specifications for an established product or product feature, based on audits and information from product development and verification processes.…
Added 13 hours ago
SO
Senior Software Engineer, Dentrix Ascend
Software of Excellence
Surrey, BC
- Full-time
This is a hands-on individual contributor role for an experienced engineer who enjoys solving complex problems, collaborating across disciplines, and supporting the growth of other…
Added 13 hours ago
MPD Technology - Automation Manager
Beyond Energy Services & Technology
Calgary, AB
Integrate third-party equipment and data: Coriolis meters, pressure transmitters, rig EDR/WITS/WITSML, hydraulics models and remote monitoring.
Added 14 hours ago
K
Field Service Engineer- Calgary, AB
Kinectrics
Calgary, AB
- Full-time
Position: Field Service Testing Engineer HVST
Added 14 hours ago
Développeur.se de logiciels sénior.e - applications dorsales / Senior Software Developer - Backend
Electronic Arts
Vancouver, BC
…and contribute to our experiences, supported by thoughtful product design, safety systems, and global reach. Our focus is on enabling more players to participate in creative expression by…
Added 14 hours ago
CC
Process Engineer
Coca-Cola Canada Bottling Limited
Toronto, ON · North York, ON
- Full-time
The Reliability & Process Engineer is the plant technical owner for asset health, chronic-loss elimination and sustained line performance. Working closely with Operations and Maintenance,…
Added 14 hours ago
OE
Junior Software Engineer – On-site (Vancouver Area)
OBD Experts
Vancouver, BC
- Full-time
We are currently scaling our SaaS product, Odomatic, with ambitious growth plans. As we expand, we are looking for a motivated Junior Software Engineer to support our team in research,…
Added 14 hours ago
M
Teleop Platform Engineer, Real-Time Systems & UI
Mecka.ai
Richmond Hill, ON
- $200,000 to $240,000 CAD / year
- Full-time
Mecka AI is building the data infrastructure layer for robotics and embodied AI.

Fresenius Medical Care

Quality Engineer

Richmond Hill, ON, Canada

Full-time

Apply About employer

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Job details

Job type: Full-time
Apply by: Nov 17, 2026
Posting language: English
Posted: Nov 3, 2026

Original job description

PURPOSE AND SCOPE:

Supports FME Canada’s mission, vision, core values and customer service philosophy. Adheres to the FME Canada Compliance Program, including following all regulatory and division/company policy requirements.

Reporting to the Head of Quality, the Quality Engineer is responsible for day-to-day execution of the CAPA, nonconformance (NC) and change control processes at the Richmond Hill site. The role supports internal, MDSAP and Health Canada audits and performs product release when required. All work must comply with Canadian medical device and, where applicable, drug GMP requirements, while staying aligned with the North America and Global QMS.

DUTIES / ACTIVITIES:

CUSTOMER SERVICE:

Responsible for driving the FME Canada culture through values and customer service standards.

Accountable for outstanding customer service to all external and internal customers.

Develops and maintains effective relationships through effective and timely communication.

Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

PRINCIPAL RESPONSIBILITIES AND DUTIES:

Lead and facilitate CAPAs from initiation through effectiveness check, meeting defined timeliness targets for initiation, impact and risk assessment, and action implementation.

Run root cause investigations using structured tools (5 Whys, fishbone, fault tree, is/is-not) and document objective evidence.

Apply ISO 14971 risk principles to assess impact, risk level and the need for field action.

Define measurable effectiveness criteria and perform effectiveness checks; escalate ineffective or overdue CAPAs.

Prepare quality metrics (e.g. CAPA, audit, complaint) and trend data for site quality reviews and Management Review.

Initiate, investigate and disposition nonconforming product and process events, including supplier and distribution NCs.

Lead Material Review Board activities, segregation and quarantine, and disposition (use-as-is, return to supplier, scrap).

Trend NCs and escalate recurring or high-risk issues to CAPA.

Assess whether an NC or complaint triggers Health Canada mandatory problem reporting or a recall and support post market vigilance or product safety in filing.

Own change requests from impact assessment through implementation and closure.

Assess changes for validation, risk, labelling, supplier, training and documentation impact.

Flag changes that may be significant changes requiring a medical device licence or drug dossier amendment, and route them to Regulatory Affairs.

Ensure changes are verified as effective before closure.

-Participate in internal audits, supplier audits and MDSAP surveillance and recertification audits.

Support Health Canada establishment licence inspections, including front room / back room roles and document retrieval.

Prepare for audits through mock audits, storyboards for open CAPAs, record reviews and SME preparation.

Draft audit finding responses and track resulting CAPAs to on-time closure.

Perform batch record and documentation review and release or reject product per site procedures, once trained and delegated.

Verify distribution and traceability records are complete and accurate for released product.

For drug products, perform release activities only as delegated by the Quality Control Department under GMP requirements.

Author and revise SOPs, work instructions and forms.

Support harmonization of Canadian site processes with the North America and Global QMS and eQMS tools.

Train site personnel on CAPA, NC and change control processes.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

Hybrid position requiring a minimum of 1-3 days/week in the office at the discretion of the manager.
Maximum 5-10 travel days per year (audits, conferences and meetings).

EDUCATION

Bachelor's degree in engineering, life sciences or a related technical discipline.
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA); ISO 13485 lead auditor training is preferred.

EXPERIENCE AND REQUIRED SKILLS:

Required:

Bachelor's degree in engineering, life sciences or a related technical discipline.

3–5 years in quality engineering or quality assurance in a regulated medical device or pharmaceutical environment.

Hands-on ownership of CAPA, nonconformance and change control records, including root cause analysis and effectiveness checks.

Working knowledge of the Medical Devices Regulations (SOR/98-282), ISO 13485:2016 and ISO 14971.

Experience participating in third-party or regulatory audits (MDSAP, ISO 13485, Health Canada or FDA).

Experience with an electronic QMS (for example QTRAK, Windchill, TrackWise or MasterControl).

• Strong technical writing skills in English.

Preferred

Experience with MDSAP audits and Health Canada establishment license inspections.

Drug GMP experience under Part C, Division 2, including batch record review and release.

Experience with renal, dialysis or other life-sustaining therapy products.

ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA); ISO 13485 lead auditor training.

Working proficiency in French.

Core competencies

Investigative rigour: gets to verified root cause, not the first plausible one.

Risk-based judgement: sizes the response to patient and compliance risk and knows when to escalate.

Audit presence: explains records clearly and calmly to auditors and inspectors.

Ownership of timelines: drives records to on-time closure and raises slippage early.

Collaboration: works across Operations, Regulatory Affairs, Supply Chain and NA Corporate Quality.

Data literacy: builds and reads CAPA and NC trend metrics to spot systemic issues.

Relationships

Internal Contacts: Sales and Marketing, Product Safety, Post market Vigilance, Regulatory Affairs, Supply Chain and NA Corporate Quality

External Contacts: Health Canada, Vendors, Medtech Association Staff and Members

SUPERVISION:

N/A

The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

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More about this job

Responsibilities

The Quality Engineer is responsible for executing CAPA, nonconformance, and change control processes while ensuring compliance with medical device and drug GMP requirements. The role also supports internal and regulatory audits, performs product release, and maintains quality metrics for the Richmond Hill site.

Requirements

Candidates must hold a bachelor's degree in engineering or life sciences and possess 3–5 years of experience in quality engineering within a regulated medical device or pharmaceutical environment. Proficiency in ISO 13485, ISO 14971, and electronic QMS tools is required, along with strong technical writing skills.

Skills

Quality Engineering
CAPA
Nonconformance Management
Change Control
Root Cause Analysis
ISO 13485
ISO 14971
Regulatory Compliance
Medical Device Regulations
Technical Writing
Audit Support
Risk Assessment
Quality Management Systems
Data Analysis
GMP
Product Release

Visa sponsorship

Not detected in the job text

Keywords

Quality Engineer
CAPA
Nonconformance
Change Control
ISO 13485
ISO 14971
Medical Device
Pharmaceutical
GMP
Health Canada
MDSAP
Root Cause Analysis
QMS
eQMS
Regulatory Affairs
Audit
Risk Management
Technical Writing
Compliance
Quality Assurance
Validation
Material Review Board
Post Market Vigilance
SOP
CQE
CQA
Batch Record Review
Traceability
Life Sciences
Engineering

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