Join ISIS !
ISIS is a French SME that provides video and communication systems solutions for operating theatres.
With nearly 600 solutions deployed in France and abroad, ISIS relies on its quality of service and R&D expertise to develop and support its customers in the hospital environment.
Do you recognize yourself ?
• Training: in training (BA/5 student) in quality, regulatory affairs, medical devices or related sector
• A first experience in the field of insurance quality is an asset
• Knowledge: understanding of the basics of quality management (ISO 13485) and in product compliance approach
• First experiences or knowledge of Regulations (MDR 2017/745) are desired
• Skills: analytical, rigorous, ability to organize and synthesize information
• Quality of relationship and editorial
• Soft skills: rigor, method, autonomy
• Languages spoken: french, english is a plus
Your new challenge
• Participate in the implementation of actions to bring the management system of the quality inrelation to the ISO 13485:2016 standard
• Create and update quality documentation
• Document management: writing, reviewing, dissemination and training
• Regularly monitor requests for product changes and QMS
• Ensure regular follow-up of non-conformities
• Update and monitor quality indicators
• Carry out regulatory monitoring
• Prepare for internal audit
• Propose areas for improvement
• Postmarket follow-up of medical devices
Company benefits
• Meal vouchers €11 (60% employer coverage)