Jobs in Canada

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Added 11 mins ago
CO
Job ID #32360: Administrative Coordinator
City of Hamilton
ON · Hamilton, Ontario
- Full-time
- Temporary
Organizes, coordinates, and participates in Department Leadership Team meetings and other meetings/events on behalf of the General Manager, including agenda development, documentation…
Added 26 mins ago
PH
Coordinator, Quality Assurance
Provincial Health Services Authority
Vancouver, BC
- Full-time
Reporting to the Manager, Laboratory Quality and Process Improvement, the Coordinator is responsible for the coordination and support of activities relating to continuous quality and…
Added 26 mins ago
PH
Direct Care Nurse
Provincial Health Services Authority
Surrey, BC
- Full-time
…experience of assigned students and new staff; provides input to the Manager and/or designated as requested on individual's progress in achieving established standards of nursing…
Added 26 mins ago
PH
Direct Care Nurse
Provincial Health Services Authority
Surrey, BC
- Full-time
…experience of assigned students and new staff; provides input to the Manager and/or designated as requested on individual's progress in achieving established standards of nursing…
Added 55 mins ago
AC
Senior Manager, Private Enterprise
ACCA Careers
Calgary, AB
- Full-time
Make an impact with our Assurance & Accounting team as a Senior Manager. This diverse team of professionals are dedicated to exceeding clients’ unique needs within a rapidly evolving…
Added 55 mins ago
AC
Manager, International Corporate Tax
ACCA Careers
Mississauga, ON
- Full-time
Working knowledge of transfer pricing tax concepts and tax efficiencies of cross-border flows
Added 55 mins ago
AC
Manager, Tax
ACCA Careers
Waterloo, ON
- Full-time
Make an impact with our Tax team as a Manager. This diverse team of professionals delivers customized tax strategies within a complex and dynamic regulatory framework. As a trusted advisor,…
Added 55 mins ago
L
Technical Sales Manager – Africa
Lallemand
Rivière-à-Pierre, QC · Rivière-à-à-Pierre, QC
- Full-time
Lallemand Biofuels & Distilled Spirits is looking for a Technical Sales Manager – South Africa to strengthen customer coverage and drive profitable growth across the African market,…
Added 55 mins ago
AC
Manager, Assurance & Accounting
ACCA Careers
Prince George, BC
- Full-time
Make an impact with our Assurance & Accounting team as a Manager. This diverse team of professionals are dedicated to exceeding clients’ unique needs within a rapidly evolving business and…
Added 55 mins ago
JP
Senior Manager, Environmental Monitoring & Microbiology
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Senior Manager, Environmental Monitoring & Microbiology
Added 1 hour ago
AC
Manager, Tax
ACCA Careers
Hanover, ON
- Full-time
Make an impact with our Tax team as a Manager. This diverse team of professionals delivers customized tax strategies within a complex and dynamic regulatory framework. As a trusted advisor,…
Added 1 hour ago
AC
Manager, Assurance and Accounting
ACCA Careers
Wiarton, ON
- Full-time
Make an impact with our Assurance & Accounting team as a Manager. This diverse team of professionals are dedicated to exceeding clients’ unique needs within a rapidly evolving business and…
Added 1 hour ago
AC
Senior Manager, Tax
ACCA Careers
Hanover, ON
- Full-time
Make an impact with our Tax team as a Senior Manager. This diverse team of professionals delivers customized tax strategies within a complex and dynamic regulatory framework. As a trusted…
Added 1 hour ago
M
Survey Crew Lead/ Senior Technologist
McElhanney
Lloydminster, AB
- Full-time
Flexible work rotations suited to your needs · Must possess and maintain a valid class 5 driver’s license with a clean driving record
Added 1 hour ago
RM
Business Development Manager
Rosslin Media
Halifax, NS
- Full-time
As a Business Development Manager, you will be expected to generate new leads and develop existing customer relationships as our client continues to grow their market share.
Added 2 hours ago
S
Store Director
sephora.com
Oakville, ON
- Full-time
…Sephora’s objectives and policies. Reporting to the District Manager the Store Director’s team can include our Talent & Business Operations Managers, Client Experience Managers, and Beauty…
Added 2 hours 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 3 hours ago
N
Fintech Intern
Naboo
Montreal, QC
- Internship
Behind every event there’s money moving between clients, venues, caterers and DMCs, often across borders, currencies and tax regimes
Added 3 hours ago
LH
Physiotherapist
Lifemark Health Group
High River, AB
- Full-time
Enthusiasm for mentoring, participating in clinic events, and sharing knowledge.
Added 3 hours ago
LH
Physiotherapist
Lifemark Health Group
Calgary, AB
- Full-time
Enthusiasm for mentoring, participating in clinic events, and sharing knowledge.
Added 3 hours ago
LH
Physiotherapist - Certified Hand Therapist
Lifemark Health Group
Calgary, AB
- Full-time
Enthusiasm for mentoring, participating in clinic events, and sharing knowledge.
Added 5 hours ago
JH
General Manager - Boutique Hotel
JRoss Hospitality Recruiters
Toronto, ON
- $120,000 to $130,000 CAD / year
- Full-time
JRoss Hospitality Recruiters is seeking an accomplished and entrepreneurial General Manager for an established hospitality organization in Toronto. This opportunity is well suited to a…
Added 5 hours ago
Senior Quanitity Surveyor - NECReg
PACT
ON · Mississauga, Ontario
This position is 5 days per week with core hours of work between approximately 8:00am–5:00pm with 1 hour lunch or as agreed upon with your manager
Added 6 hours ago
EC
Event Experience and Design Specialist - Banff - Part Time
Encore Canada
Banff, AB
- Part-time
2-3 days in office at the Banff location in a hybrid model, ability to work at events onsite 1-2 times a week
Added 6 hours ago
SM
Manager, Finance, Performance & Analytics
Stevenson Memorial Hospital
Alliston, ON
- Full-time
Reporting to the Vice President, Corporate Services & Chief Financial Officer, the Manager, Finance, Performance and Analytics supports the hospital's strategic objectives, performance…

Fresenius Medical Care

Quality Engineer

Richmond Hill, ON, Canada

Full-time

Apply on LinkedIn About employer

Applications open in a new tab.

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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Work requirements

Jobs in Canada