Quality Assurance Engineer – Medical Devices

il y a 3 semaines


Massy, Palaiseau, France Sensome Temps plein

Company

At 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.


Mission

This is an excellent chance to become part of a cohesive team united by a shared vision, working

alongside 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 be:

  • Maintain and ensure that the Quality Management System is effective, compliant and fit for purpose to meet Sensome’s needs.
  • Coordinate risk management activities.
  • Generate, review and edit procedures, and other applicable documentation.
  • Facilitate and participate in nonconformities resolution activities.
  • Support the planning and coordination of corrective and preventive actions, changes, deviations, and other quality related activities.
  • Conduct internal and external audits.
  • Perform product quality control (incoming inspection, batch release).
  • Manage and coordinate qualifications and evaluations of suppliers.
  • Support manufacturing team in management of documents and records.
  • Support regulatory team and participate in the transition to new Medical Device Regulation.
  • Follow changes in the regulatory landscape and provide guidance and recommendations to the team.
  • Collaborate with an interdisciplinary Team.


Your profile

  • Master 2 engineer.
  • French and English: read, written and spoken.
  • Expected experience: minimum 3 years in quality management/quality assurance in the medical device industry.
  • Methodical, pragmatic, good communication skills, positive and open minded.
  • Ability to work in a multi-cultural environment and in a team.
  • Ability to manage your activity independently with a keen sense of alertness.
  • Ability 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?


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