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Added 1 min ago
SM
Job Title: RQ00393 – Database Admin I
S M Software Solutions Inc
Fredericton, NB
- Internship
Must have 3+ years of Database Administration Experience
Added 1 min ago
SM
Job Title: RQ00393 – Database Admin I
S M Software Solutions Inc
Fredericton, NB
- Internship
Must have 3+ years of Database Administration Experience
Added 1 min ago
SM
RQ11870 – Software Developer – Full Stack – Senior
S M Software Solutions Inc
Toronto, ON
- Internship
Work Arrangement: Onsite – 5 Days per Week
Added 1 min ago
SM
RQ11870 – Software Developer – Full Stack – Senior
S M Software Solutions Inc
Toronto, ON
- Internship
Work Arrangement: Onsite – 5 Days per Week
Added 1 min ago
RS
Phased Array Technician - Pipeline Integrity
Rockwood Service Corporation
Edmonton, AB
- Full-time
Echo NDE is seeking Phased Array Technicians to support our PLI division across Western Canada and the United States.
Added 46 mins ago
S
Manager, Planning and Project Controls, BC Health Workday
Sanya’k̓ula
BC · British Columbia, Canada
- Full-time
…systems in the health organizations with a single, unified technical system that will standardize and modernize HR and payroll services. It is a significant transformation in BC and is…
Added 46 mins ago
PH
Manager, Planning and Project Controls, BC Health Workday
Provincial Health Services Authority
BC · British Columbia, Canada
- Full-time
…systems in the health organizations with a single, unified technical system that will standardize and modernize HR and payroll services. It is a significant transformation in BC and is…
Added 1 hour ago
A
Space & Defense Systems (SDS) Manager – Business Execution & Engineering Operations
ABB
Québec, QC
- Full-time
…supply chain coordination, quality, deployment, and lifecycle support. You will drive operational excellence, customer satisfaction, profitability, compliance, and long-term business growth…
Added 1 hour ago
A
Senior Field Service Technician
ABB
Mississauga, ON
- $90,000 to $120,000 CAD / year
- Full-time
As a Senior Field Service Technician in Robotics, you will be responsible for delivering high-quality technical support and service to our customers.
Added 2 hours ago
ES
National Account Manager
Essex Solutions
ON · Simcoe, ON
- Full-time
Work with leadership to develop market and account strategies that support overall business growth.
Added 3 hours ago
UG
Data Analyst
UNB Geodesy & Geomatics Engineering
Fredericton, NB
- Full-time
Provide research support to users in the DataNB's lab.
Added 3 hours ago
KE
RMA Coordinator
Kontron Europe
Boisbriand, QC
- Full-time
Escalation Management: Identify at-risk situations (delays, quality or technical issues) and ensure proper follow-up until resolution;
Added 5 hours ago
A
Senior Communications Designer
Actalent
Toronto, ON
- $80 to $100 CAD / hour
- Contract
Work EnvironmentHybrid model working 2 days in office at any location across the GTA
Added 5 hours ago
A
Field Service Technician
ABB
Coquitlam, BC
- Full-time
As a Senior Field Service Technician, you will be responsible for delivering high-quality technical support and service to our customers.
Added 5 hours ago
R
Senior Broadcast Technologist (T & I) (On-site)
Radio-Canada
Toronto, ON
- Full-time
We are looking for a Broadcast and IT Systems Specialist to support the studio, content creation, and presentation groups with technical issues as well as help implement groundbreaking…
Added 8 hours ago
MC
Vice President, Finance & Business Operations
Make-A-Wish Canada
Toronto, ON
- Full-time
…organizational performance, and build the capabilities needed to support sustainable growth and greater mission…
Added 8 hours ago
RM
IT Business Analyst (Tech)
REDPATH MINING
Vaughan, ON
- Full-time
The IT Business Analyst role is to support the Business Applications team in the planning, design, development, and support of efficient business systems within core organizational…
Added 8 hours ago
P–
Manager, Planning and Project Controls, BC Health Workday
PHSA – Corporate
BC
- Full-time
- Temporary
…systems in the health organizations with a single, unified technical system that will standardize and modernize HR and payroll services. It is a significant transformation in BC and is…
Added 9 hours ago
L
Senior AI/ML Engineer
lululemon
Vancouver, BC
- Full-time
…running, training, and other athletic pursuits. Setting the bar in technical fabrics and functional design, we create transformational products and experiences that support people in…
Added 9 hours ago
L
Applied AI/ML Scientist
lululemon
Vancouver, BC
- Full-time
…running, training, and other athletic pursuits. Setting the bar in technical fabrics and functional design, we create transformational products and experiences that support people in…
Added 9 hours ago
GC
Senior Product Manager, Ad Monetization
Game Companies
Toronto, ON
- Full-time
Support our live operations business lines on an ongoing basis, providing technical insight and expertise into how to fix problems and triage issues
Added 9 hours ago
R|
Research Associate
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
Perform administrative services in support of the lab, including, scheduling appointments, word processing, and ordering materials as required. Assist in application for animal and…
Added 9 hours ago
R|
Licensed Practical Nurse (LPN) or Research Nurse
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
Support the Team: Assist with various tasks as directed by the manager,
Added 9 hours ago
YO
CRE - Valuation Analyst
YFK Office Lease
Toronto, ON · Greater Toronto Area, Canada
- Full-time
…commercial real estate assets, prepare valuation models, and support investment decision-making through rigorous financial analysis. Daily responsibilities include performing cash flow…
Added 9 hours ago
C
Concrete SME - Superintendent
Chandos
Calgary, AB
- Full-time
- On-site
Our vision is to emerge as Canada’s premier technical builder, distinguished by our relentless pursuit of innovation, collaboration, and sustainability in all that we do.

Closed listing

FOP Consultants

Specialist/Project Manager, quality assurance

QC, Canada

Full-time · Temporary

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Job type: Full-time · Temporary
Posting language: English
Posted: Nov 16, 2023

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Original job description

Archived listing. The details below describe a past opening.

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for quality assurance consultants motivated to carry out mandates. The main missions would be to review and approve quality documents (SOP, protocols, etc.), collaborate on customer complaints, write non-conformity reports, investigation, change control, CAPA, present performance indicators and perform all quality assurance tasks related to medical devices.

Main responsibilities :

Without limitation, the main tasks involve:

Manage projects related to quality assurance procedures and documentation;
Revise and write quality documents (SOP, protocols, instructions, etc.);
Document customer complaints and ensure that investigations are opened to resolve them;
Provide KPI data to assess business performance;
Act as a support to respond to requests on the quality of medical products;
Carry out regulatory monitoring to learn about GMPs related to medical devices;
Collaborate with teams from different departments to resolve quality issues related to deviations, change control, CAPA and investigations;
Participate in any project to improve the quality assurance system;
Participate in weekly or monthly meetings on regulatory files;
Provide solutions to problems encountered and perform all tasks relevant to the mandate.

Qualifications :

Bachelor's or Master's degree in science (medical technology, chemistry, biochemistry, etc.) engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline;
1 (one) to 10 (ten) years of experience in the medical device, hospital or related industry;
Project management (an asset);
Experience in quality assurance in the field of medical devices, pharmaceuticals;
Knowledge of ISO 13485 standards;
Knowledge of FDA, Health Canada regulations;
Knowledge of classes I, IIa, IIb and III of medical devices;
Excellent command of MS Office suite;
Good communication and writing skills in French and English;
Mobility (an asset).

Personal skills :

Leadership;
Rigor et discipline;
(Organize), able to manage several projects;
Analytical and critical mindset;
Perseverance;
Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

Competitive wages;
Group insurance;
Professional insurance;
Remote work, according to the customer needs;
Vacations: 3 weeks;
Paid sick leave: 3 days;
Monthly transportation fees;
Career advancement opportunity;
Continuing education.

About employer

More about this job

Responsibilities

The quality assurance consultant at FOP Consultants will manage quality projects and write or revise SOPs and protocols. They will document customer complaints, drive investigations and CAPA, and track KPIs for medical device clients.

Requirements

Candidates need a bachelor's or master's degree in science or engineering and one to ten years of medical device or pharmaceutical quality experience. They must know ISO 13485, FDA and Health Canada rules, and medical device classes I to III, and write well in French and English.

Skills

ISO 13485
FDA regulations
Health Canada regulations
Medical device classes I, IIa, IIb, III
CAPA
Change control
Deviation management
Non-conformity reporting
Complaint investigation
SOP writing
Protocol writing
KPI reporting
GMP
Regulatory monitoring
Project management
MS Office
Technical writing
French
English
Root cause analysis

Benefits

Group insurance
Professional insurance
Three weeks of vacation
Paid sick leave
Monthly transportation fees
Career advancement opportunity
Continuing education

Keywords

quality assurance
medical devices
ISO 13485
FDA
Health Canada
CAPA
non-conformity
change control
deviations
SOP
KPI
regulatory compliance
GMP
project management
MS Office
consultant
temporary
remote work

Seniority

Mid level

Perks

Generous paid time off
Transit support

Tools

MS Office

Languages

English
French

Fields of study

medical technology
chemistry
biochemistry
biomedical engineering
mechanical engineering

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Jobs in Canada