Ingénieur Assurance Qualité R&D H/F
Core
R&D Quality Engineer ensuring regulatory compliance and risk management for sterile injectable aesthetic medicine products.
Role type
Senior IC Quality Engineer (R&D)
Builds
New sterile injectable aesthetic medicine products (hyaluronic acid-based)
Domain
Medical Aesthetics / Pharmaceutical R&D
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, Risk Management (ISO 14971), Validation of Cleaning & Contamination, Regulatory Compliance (EU/US), Project Management, Technical Writing
Preferred skills
Pharmaceutical or Medical Device background, Sterilization processes, Change management
Technologies
MS Office (Word, Excel, PowerPoint)
Responsibilities
Lead design control processes for new product development, Manage risk assessments throughout the product lifecycle, Ensure compliance with quality and regulatory requirements, Coordinate corrective and preventive actions for non-conformities, Support investigations into quality issues, Deploy quality culture to project partners
Seniority
Mid-Senior, hands-on IC