POSITION DESCRIPTION

FOP CONSULTANTS is looking for Verification and Validation Engineers at the senior level motivated to deliver on mandates for its clients in the medical device sector. The mandate is to plan and execute the verification and validation of medical devices and to ensure requirements-risks-testing traceability, validate software (IEC 62304) and usability (IEC 62366), and document results in support of regulatory submissions. The senior scope is further to define the site validation strategy and arbitrate technical choices and to mentor intermediate consultants and review their deliverables.

KEY RESPONSIBILITIES

- Develop design verification and validation plans.
- Draft and execute performance, safety and reliability test protocols.
- Ensure traceability between requirements, risks and test results.
- Validate medical device software in accordance with IEC 62304.
- Conduct usability engineering studies (IEC 62366).
- Analyze results, document deviations and draft reports.
- Support regulatory submissions and audits.
- Define the site validation strategy and arbitrate technical choices.
- Mentor intermediate consultants and review their deliverables.
- Represent the client during regulatory inspections and audits

CANDIDATE PROFILE

- Bachelor's or master's degree in 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 Verification and Validation Engineer.
- Sector standards: ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR 2017/745, MDSAP.
- Tools and systems: MS Office suite, Veeva Vault, TrackWise, Kneat, MS Project.
- Hold one of the following certifications: ASQ CQE, ISPE GAMP 5, Six Sigma Green Belt.
- The following are considered assets: PMP, ASQ CQA, Six Sigma Black Belt.
- 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 setting 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.

📌 Verification and Validation Engineers (Sr.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City