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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Design Verification and Validation activities, ensuring compliance with ISO 13485, MDR, and FDA regulations while managing quality documentation and risk management processes. Proficient in both French and English, with a strong background in Quality Assurance and Regulatory Affairs within the medical device industry.
Highest-signal resume keywords
Design Verification & ValidationQuality AssuranceRegulatory AffairsISO 13485 ComplianceClass III Medical Devices
ATS Keywords
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Hard Skills
Design VerificationValidation ActivitiesQuality DocumentationRisk ManagementTraceabilityNonconformities ManagementCAPAs ManagementTechnical SupervisionQuality Processes ImprovementMedical Device Regulations
Tools & Technologies
Microsoft Office
Industry Keywords
ISO 14971MDRFDA 21 CFR Part 820Biomedical EngineeringMechanical EngineeringQuality ManagementV&V Best PracticesInternal AuditsExternal AuditsFluency in French and English
About the role
Key responsibilities & impact- Ensure rigorous, compliant, and well-documented execution of Design Verification & Validation activities, from plans and protocols through final reports.
- Define, draft, review, and approve quality documentation associated with V&V activities.
- Ensure traceability between requirements, tests, results, and acceptance criteria.
- Contribute to product risk management in accordance with ISO 14971.
- Ensure compliance with ISO 13485, the MDR, FDA 21 CFR Part 820, and internal procedures.
- Participate in internal and external audits as the Quality subject-matter expert for V&V and Design Control.
- Contribute to the continuous improvement of Quality processes, methods, and tools.
- Provide technical supervision to an experienced engineer and support project and R&D teams on quality requirements and V&V best practices.
- Participate in the management of nonconformities and CAPAs related to V&V activities.
Requirements
What you’ll need- Education: Master’s degree or equivalent (Bac+5 minimum) in biomedical engineering, quality, materials, mechanical engineering, or a related field.
- Strong experience in Quality Assurance, Regulatory Affairs, and/or V&V within the medical device industry.
- Experience with Class III medical devices is highly valued.
- Fluency in French and English, both written and spoken.
- Proficiency in Microsoft Office.
Benefits
Comp & perks- Passion for science and a true team spirit
- Inclusive environment
- Collaboration and individual development
- Opportunity to grow through diverse projects under a full-service “one-stop provider” model encompassing FSP and consulting services
- Opportunity to work alongside recognized experts
- Contribution to the development of scientific, operational, and human expertise
- An environment that values natural talents, encourages boldness, and supports the development of individual potential