Ingénieur Qualité CDD
Core
Manage project quality activities (AQ) for site investment projects, ensuring quality of products, processes, and changes in collaboration with Engineering and Validation teams.
Role type
Project Quality Engineer
Builds
Quality assurance for medical device manufacturing projects
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change Control management, Project Quality Management, Regulatory knowledge (FDA, ISO 13485, GMP), Quality tools (NC-CAPA, root cause analysis), Lean/Six Sigma, Audit execution, KPI tracking, Process validation support, Stakeholder management
Preferred skills
Medical device industry experience, Trackwise proficiency, English fluency
Technologies
NC-CAPA, Trackwise
Responsibilities
Evaluate quality impacts of change controls, Define and approve validation strategies, Track project quality actions against execution plans, Review and approve project quality documentation, Lead internal and external audits, Analyze quality trends and propose improvements, Support validations and qualifications, Train project teams on quality requirements
Seniority
Mid-level, hands-on IC