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il y a 8 heures

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Part-Time Quality & Design Assurance Specialist (2 days/week) – Class III Medical DeviceAs a consulting company specialized in medical devices, we are currently looking for a Quality & Design Assurance Consultant to support one of our clients developing an innovative Class III medical device, currently in design change and clinical investigation phase.This mission is ideal for a senior QA/RA profile who enjoys working hands-on in R&D environments and collaborating closely with engineering teams.You will support the client on a variety of Quality and Design topics, including:Component management for the console (internal production)Internal inspections and continuous improvement of existing practicesNon-conformities management and CAPA plans:Audit-related NCProcess improvement NCIncoming inspection & assembly NC (console)Contribution to Design History File / Technical Documentation updates:Testing related to design changesVerification & Validation activitiesRisk management updatesBiocompatibility documentationYou will work directly on-site with the engineering team in a highly dynamic development context.Profile we are looking for :Strong experience with Class III medical devicesSolid expertise in Design Control, DHF, V&V, Risk ManagementComfortable in design change / R&D environmentsHands-on mindset, able to collaborate closely with engineersExperience with internal manufacturing is a plusAutonomous, pragmatic, and improvement-orientedPosition to be filled ASAPJoin us for an owl-some collaboration

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