Quality Assurance Engineer – Medical Devices
il y a 3 semaines
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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