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specialists in quality assurance (Int.)

FOP Experts Conseils inc.

202-9420 Boulevard Taschereau, Brossard,QC

Salary To be discussed
37.50 to 40.0 h - Full time
Contract ,Permanent ,Telecommuting job
Day shift work
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3 positions to fill as soon as possible

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Benefits

Commitment to work-life balance
Disability insurance
Floating leave days
Insurance
On-going training
Paid leave
Paid sick leave
Performance bonuses
Reimbursement for public transportation

Description

POSITION DESCRIPTION

FOP CONSULTANTS is looking for specialists in quality assurance at the intermediate level motivated to deliver on mandates for its clients in the medical device sector. The mandate is to maintain the medical device quality system in accordance with ISO 13485, MDSAP and the QMSR and to manage non-conformances, CAPA and complaints, conduct audits and support regulatory inspections.

KEY RESPONSIBILITIES

Maintain and improve the quality management system in accordance with ISO 13485 and MDSAP.
Manage non-conformances, CAPA, complaints and changes.
Conduct internal and supplier audits.
Review device history records (DHR) and release products.
Support audits by notified bodies, the FDA and Health Canada.
Track quality indicators and lead management reviews.
Ensure compliance with 21 CFR 820 (QMSR) and the EU MDR.

CANDIDATE PROFILE

Bachelor's or Master's degree in science (medical technology, chemistry, biochemistry, etc.) engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline.
Five (05) to ten (10) years of industry experience.
Three (03) to seven (07) years of experience as a Specialist in Quality Assurance.
Sector standards: ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR 2017/745, MDSAP.
Tools and systems: MS Office suite, TrackWise, Veeva Vault, SAP QM, Power BI.
Hold one of the following certifications: ASQ CQA, ASQ CQE, ISO 9001 Internal Auditor.
The following are considered assets: ASQ CMQ/OE, Six Sigma Green Belt, ISO Lead Auditor.
Experience in Canadian public or private organizations.
Language: French and English

WORK MODE

Remote, Hybrid, On-site

WHAT WE OFFER

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

Competitive compensation that reflects your expertise;
Complete protection through our group insurance plans;
Professional liability insurance so you can practise with confidence;
Remote-work flexibility, based on client needs;
3 weeks of vacation to recharge;
3 paid sick days, to take care of yourself;
A monthly allowance for your transportation costs;
Real opportunities for advancement within the organization;
Ongoing access to training to grow your skills.

Equal Opportunity Employer

This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.

Requirements

Level of education

University

Diploma

BAC

Completed

Work experience (years)

3-5 years

Written languages

Fr : Advanced

En : Intermediate

Spoken languages

Fr : Advanced

En : Intermediate

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