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Added 8 mins ago
MP
Funeral Director, Funeral Services
Mount Pleasant Group
Pickering, ON
- $41.4 to $46.43 CAD / hour
- Full-time
…ongoing professional development to ensure the highest quality of service to the…
Added 8 mins ago
EK
Shift Manager
Earls Kitchen + Bar
Kelowna, BC
- $25 to $28 CAD / hour
- Full-time
We are looking for a passionate Shift Manager to grow our leadership team. As a Shift Manager, you’re committed to being your best self and working with integrity as you learn how to…
Added 8 mins ago
FC
Administrative Assistant
Federated Co-operatives Limited
Dryden, ON
- Full-time
The Team: You will work closely with Drivers and Service Technicians, and will report into the Manager, Propane Operations. This team strives to cultivate a culture of collaboration and…
Added 8 mins ago
SD
Merchandiser, Hourly Part Time Flexible Shifts
Shoppers Drug Mart
Sooke, BC
- Part-time
Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do.
Added 8 mins ago
W
(CAN) Self Checkout Attendant
Walmart
North Vancouver, BC
- Part-time
…reassuring way and escalate cash or technical issues to the Customer Service…
Added 8 mins ago
LC
Apparel Department Manager Part Time Day
Loblaw Companies Limited
Toronto, ON
- Part-time
We’re looking for Talented Passionate Leaders with a proven record of delighting customers and growing sales. As a Manager in, you will have an immediate impact on sales and customer…
Added 8 mins ago
LC
Meat Department Manager Part Time Day Greenlight Requisition
Loblaw Companies Limited
Toronto, ON
- Part-time
We’re looking for Talented Passionate Leaders with a proven record of delighting customers and growing sales. As a Manager in, you will have an immediate impact on sales and customer…
Added 8 mins ago
CI
Supervisor (Part Time)
Carters Inc.
Mississauga, ON
- Part-time
Support store team with Asset Protection through a consistent level of customer service, safety awareness, and operational controls
Added 23 mins ago
Operations Support Representative International Gateway
Purolator
Mount Hope, ON
The Support Representative, US & International Gateway, provides US/International service options to our customers by scanning, verifying shipper/receiver address, shipment contents,…
Added 39 mins ago
NF
Produce Department Manager Full Time Day
No Frills
Burnaby, BC
- Full-time
We’re looking for Talented Passionate Leaders with a proven record of delighting customers and growing sales. As a Manager in, you will have an immediate impact on sales and customer…
Added 39 mins ago
LC
Assistant Front Store Manager, Hourly Part Time Day
Loblaw Companies Limited
Oshawa, ON
- Part-time
Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do.
Added 39 mins ago
LC
Assistant Front Store Manager, Hourly Full Time Flexible Shifts
Loblaw Companies Limited
Oshawa, ON
- Full-time
Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do.
Added 39 mins ago
LC
Merchandiser, Hourly Part Time Flexible Shifts
Loblaw Companies Limited
Ottawa, ON · Nepean, ON
- Part-time
Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do.
Added 1 hour ago
L
Dairy/Frozen Assistant Department Manager - Full Time
Longo's
Oakville, ON
- Full-time
Provide exceptional customer service to all Team Members, Customers and Vendors
Added 1 hour ago
DG
Catering Sous Chef
Dexterra Group
Mississauga, ON
- Full-time
Under the general supervision of the Catering Chef Manager, the Sous Chef oversees organizing, planning, preparing and executing the preparation of all catering events.
Added 1 hour ago
SD
Merchandiser, Hourly Part Time Flexible Shifts Greenlight Requisition
Shoppers Drug Mart
Toronto, ON
- Part-time
Join a locally owned and operated store to help deliver health, beauty and convenience services in your community, and keep the customer at the centre of everything you do.
Added 1 hour ago
SD
Pharmacy Manager, Hourly Full Time Flexible Shifts
Shoppers Drug Mart
Saskatoon, SK
- Full-time
Commitment to providing exceptional customer service
Added 1 hour ago
BC
Head of Operations
BIOAGRINEC CONSULTING & RECRUTEMENT
Canada
- Full-time
Lead and oversee day-to-day business operations to ensure efficiency, productivity, and service excellence.
Added 1 hour ago
TH
Lumber Sales Associate Part Time - 7170 Lethbridge
The Home Depot Canada
Lethbridge, AB
- Part-time
Sales Associates provide fast, friendly service by actively seeking out customers to assess their needs and provide assistance. Sales Associates have an emphasis on department and product…
Added 1 hour ago
GE
Stage Bar Host
Grey Eagle Resort & Casino
Calgary, AB
- Full-time
…in a timely manner. Emphasis must be placed on exceptional customer service as the Host-Hostess in many instances will be the first contact that our customers will have with an employee.…
Added 1 hour ago
GE
Bar Assistant - Stage Bar
Grey Eagle Resort & Casino
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- Full-time
Under the direction of the Front of House (FOH) Outlets Manager and Supervisor, the Bar Porter is responsible for supporting bar operations by assisting Bartenders and maintaining clean,…
Added 1 hour ago
GE
Blaze Bar & Grill Server Assistant
Grey Eagle Resort & Casino
Calgary, AB
- Full-time
Under the direction of the Food and Beverage Manager, Shift Supervisor, the Server position is applicable to the Bingo Hall, Buffet, Blaze Restaurant, Stage Bar, Gaming Floor and the Hot…
Added 1 hour ago
TH
Millwork Sales Associate Part Time - 7036 Medicine Hat
The Home Depot Canada
Medicine Hat, AB
- Part-time
Sales Associates provide fast, friendly service by actively seeking out customers to assess their needs and provide assistance. Sales Associates have an emphasis on department and product…
Added 1 hour ago
GE
Event Centre - Food and Beverage Supervisor
Grey Eagle Resort & Casino
Calgary, AB
- Full-time
Under the direction of Food and Beverage Manager; Event Supervisor duties will include, but are limited to oversees all aspects of a events, including set-up, food service, bar service and…
Added 1 hour ago
GE
Blaze Bar & Grill Server
Grey Eagle Resort & Casino
Calgary, AB
- Full-time
Under the direction of the Outlets Manager and Outlet Supervisor, the Server is responsible for providing professional, efficient, and attentive food and beverage service to guests in…

Fresenius Medical Care

Quality Engineer

Richmond Hill, ON, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 27, 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

Own and drive CAPA, nonconformance, and change control processes, including investigations, risk assessments, effectiveness checks, documentation, and timely closure. Support audits and regulatory inspections, perform delegated product release activities, maintain quality system documentation, and provide quality metrics and training.

Requirements

Requires a bachelor’s degree in engineering, life sciences, or a related technical discipline and 3–5 years of quality engineering or assurance experience in a regulated medical device or pharmaceutical environment. Candidates need hands-on CAPA, nonconformance, and change control experience, knowledge of Canadian medical device regulations and ISO 13485/14971, audit experience, electronic QMS experience, and strong English technical writing skills.

Skills

CAPA Management
Root Cause Analysis
Nonconformance Management
Change Control
Risk Assessment
ISO 13485
ISO 14971
Medical Device Regulations
Audit Support
MDSAP Audits
Health Canada Compliance
GMP Compliance
Electronic Quality Management Systems
Technical Writing
Quality Metrics and Trend Analysis
Batch Record Review

Visa sponsorship

Not detected in the job text

Keywords

CAPA
Nonconformance
Change Control
Root Cause Analysis
5 Whys
Fishbone Analysis
Fault Tree Analysis
Is/Is-Not Analysis
ISO 14971
ISO 13485:2016
Medical Devices Regulations (SOR/98-282)
MDSAP
Health Canada
GMP
Part C, Division 2
Electronic QMS
QTRAK
Windchill
TrackWise
MasterControl
Material Review Board
Post-Market Vigilance
Product Release
Batch Record Review
Supplier Audits
Management Review
ASQ Certified Quality Engineer
ASQ Certified Quality Auditor
ISO 13485 Lead Auditor Training
Risk Assessment

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