Senior Ingénieur Assurance Stérilité & Salle Blanche
Core
Garantir la conformité des produits aux exigences réglementaires pour les dispositifs médicaux en maîtrisant les procédés de nettoyage, salle blanche et stérilisation.
Role type
Senior Quality Assurance Engineer (Sterility & Cleanroom)
Builds
Production of compliant medical devices
Domain
Medical devices / Pharmaceutical manufacturing
Deliverable
client delivery
Required skills
Sterilization process validation, Cleanroom management, Statistical analysis, CAPA management, Change control, Risk analysis, Regulatory documentation, Supplier management
Preferred skills
Contamination control, Continuous improvement projects
Technologies
Statistical analysis tools, Monitoring systems
Responsibilities
Pilot validation and requalification of sterilization and cleaning processes, Monitor environmental and product data trends, Manage non-conformities and corrective actions, Lead change control activities, Participate in internal and external audits, Report to QA management
Seniority
Senior, hands-on IC
