POSITION DESCRIPTION

FOP CONSULTANTS is looking for specialists in quality assurance at the senior 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. The senior scope is further to define the site quality strategy and compliance roadmap and to mentor intermediate consultants and review their deliverables.

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.
- Define the site quality strategy and compliance roadmap.
- Mentor intermediate consultants and review their deliverables.
- Lead client and regulatory audits and their action plans.

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.
- Minimum ten (10)



years of industry experience.
- Eight (08) to fifteen (15) 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, In office

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.

📌 specialists in quality assurance (Sr.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City