Eindhoven, North Brabant, Netherlands
Quality & Regulatory skills -Knowledge of quality management system regulations -Develop, implement and deploy quality management system fulfilling ISO-13485:2003 and 21 CFR 820 -Knowledge of world wide regulation with respect to post market surveillance / adverse event reporting -Trainer capabilities -Motivator in generating quality awareness -Auditor capabilities -Knowledge of design control, risk management and configuration management -Lean Product Developer / scientist skills -Develop highly regulated medical devices (knowledge of GMP, GLP, ISO, IVD directive, FDA regulations) -Knowledge of biochemical and molecular technologies -Develop product from initial design to regular manufacturing. -Act as interface between Operations and R&D -Expert in Design Control aspects -Know how clinical diagnostics Project Manager skills -Lead multidisciplinary teams (Molecular Diagnostics, IT, Biomathematics, Engineering, Regulatory affairs, QA, marketing and Operations) -Manage multidisciplinary project team(s) worldwide (United States, France, Netherlands) -Leading the definition of strategies within projects -Organize projects (Define project team, write plan, set up communication structure, perform project within timelines ) -Accurate follow up on progress and issues General -Driven personality -Team builder -Trouble shooter -Coach