Nicolas Roth

Manager of Project Quality and Risk Management - Projects Direction @Air Liquide

Grenoble, FR
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Manager of Project Quality and Risk Management - Projects Direction @Air Liquide

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Transversal management of the overall Project Quality teams across all four Business Units : Risk assessment during project acquisition and Product Assurance during execution of double-digit-M€ industrial development projects (cryogenic plants for Big Science, energy transition, space equipments)• Continuous improvement & sustaining of the New Product Introduction Projects (Stage-Gate) quality process

EDUCATION

2000 — 2003

Ecole Nationale Supérieure de Mécanique et d'Aérotechnique

Master of Engineering (M.Eng.), Ingénierie mécanique

1997 — 2000

lycée ORT

Classes Préparatoires MPSI & PSI

SKILLS

Product DevelopmentRegulatory SubmissionsAffaires RéglementairesConception De ProduitMedical Device Product DevelopmentIso 13485International Project ManagementMedical Device DirectiveValidationGénie BiomédicalAssurance QualitéAnsmSystème QualitéLancement De ProduitManagementProduct LaunchLeadership D'équipe MultifonctionnelleDispositif MédicalMedical DevicesOrthopédieContrôle Du Processus De ConceptionAmélioration ContinueR&DContinuous Improvement21 Cfr

ABOUT NICOLAS ROTH

20 years of R&D and Quality experience in highly demanding industry (Medical Device, Space) Global vision result-oriented.Structuration of cross-functional processes.Leadership in R&D and RA/QA team management.Continuous Improvement (problem solving).Medical devices Design and Development (focused on User Needs & Validation).Quality System & Regulatory Affairs (FDA, CE).Industrialization

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Nicolas Roth — Manager of Project Quality and Risk Management - Projects Direction at Air Liquide in Grenoble, FR | Unifers