Tech Quality Assurance Specialist
il y a 3 semaines
We are seeking a highly skilled Quality Assurance Specialist to join our team at Sensome. As a Quality Assurance Specialist, you will play a crucial role in ensuring the effectiveness, compliance, and fitness for purpose of our Quality Management System.
Key Responsibilities:- Maintain and ensure 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.
- 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.
- 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%.
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