Location : Antony 92, France
Description : Responsible for optimization and control of industrialization process (equipment, methods…), in compliance with quality and regulatory requirements and specifications. Delivers a regular reporting. Implements preventive maintenance plans, operational methods and dysfunction indicators. Develops and validates the technical feasibility of industrial development project and process optimization. Implements and follows-up action plans. Manages process qualification (QI, QO, QP), risk analysis (ISO 14971 standards), subcontractors identification and follow-up. Develops and manages Device Master Record.
Requirements : Higher education diploma (Engineering School, Master Degree DEA or DESS), specialized in industrialization processes, mechanical, biomedical. Working experience of 3 years in the medical device industry (ideally Spine) or aeronautics industry. Confirmed operational with multiple technical skills enabling an autonomous management of the industrialization project. Pragmatic and ability for synthesizing information in order to communicate a precise and regular reporting. Fluent in English, master of MS Office suite, Solidworks, MS project and excellent knowledge of 93/42/CEE directives, ISO 13485 and ISO 14971 standards. Excellent knowledge in biochemistry (sterilization) and biology. Strong base knowledge of manufacturing process. Basic financial knowledge for budget monitoring. Must have the ability to multi-task in order to oversee multiple projects at one time. Must be a motivated self-starter, able to work independently. Must be flexible, creative and proactive. Must have an analytical capability and ability to innovate and propose the right solutions. Must be a team player with the ability to work with staff at different organizational levels across various business units.
Should you be interested by this job opportunity, please send your resume and application letter to :
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