Quality Assurance Engineer - Medical Devices

  • Massy
  • Sensome
CompanyAt Sensome, we did not know that it was impossible, so we simply did it. Spin-off from Ecole Polytechnique, we develop a unique sensor technology to turn invasive medical devices and implants into connected healthcare devices. For our first product, we integrated this technology on a neurovascular guidewire for the exploration of brain vessels to streamline stroke intervention, and to save lives and avoid severe disabilities. You will be collaborating with a multidisciplinary team of passionate individuals who support one another in their mission to provide cutting edge technology for patients.MissionThis is an excellent chance to become part of a cohesive team united by a shared vision, workingalongside other seasoned professionals in their respective areas of expertise. Each day will bring new and different challenges! You'll take on a diverse range of responsibilities encompassing multiple aspects of Quality Assurance.In particular, your mission, if you accept it, will beMaintain and ensure that the Quality Management System is effective, compliant and fit for purpose to meet Sensome’s needsCoordinate risk management activitiesGenerate, review and edit procedures, and other applicable documentationFacilitate and participate in nonconformities resolution activitiesSupport the planning and coordination of corrective and preventive actions, changes, deviations, and other quality related activitiesConduct internal and external auditsPerform product quality control (incoming inspection, batch release)Manage and coordinate qualifications and evaluations of suppliersSupport manufacturing team in management of documents and recordsSupport regulatory team and participate in the transition to new Medical Device RegulationFollow changes in the regulatory landscape and provide guidance and recommendations to the teamCollaborate with an interdisciplinary TeamYour profileMaster 2 engineerFrench and English: read, written and spokenExpected experience: minimum 3 years in quality management/quality assurance in the medical device industryMethodical, pragmatic, good communication skills, positive and open mindedAbility to work in a multi-cultural environment and in a teamAbility to manage your activity independently with a keen sense of alertnessAbility to analyze, make informed decisions and continuously improve😎 Supplementary information and employee benefits Permanent contract,Full-time job (partial remote work possible),Electronic meal vouchers 😊,RTT,Complementary health insurance + Advanced medical support platform,Reimbursement of transport costs at 50%Ready to change the world with us?