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Regulatory Compliance Expert
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About Sensome
Sensome is a cutting-edge technology company that develops innovative sensor solutions for the medical device industry. Our mission is to revolutionize healthcare by providing connected devices that improve patient outcomes and save lives.
Job Summary
We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the effectiveness and compliance of our Quality Management System. Your primary responsibilities will include:
- Maintaining and improving our Quality Management System to meet the needs of Sensome.
- Coordinating risk management activities and generating, reviewing, and editing procedures and documentation.
- Facilitating and participating in nonconformities resolution activities and supporting the planning and coordination of corrective and preventive actions.
- Conducting internal and external audits and performing product quality control.
- Managing and coordinating qualifications and evaluations of suppliers and supporting the manufacturing team in document and record management.
- Collaborating with the regulatory team to ensure compliance with the Medical Device Regulation and providing guidance and recommendations to the team.
Requirements
To be successful in this role, you will need:
- A Master's degree in Engineering or a related field.
- Fluency in French and English, both written and spoken.
- At least 3 years of experience in quality management or quality assurance in the medical device industry.
- Methodical and pragmatic approach, with excellent communication skills and a positive attitude.
- Ability to work independently and as part of a team, with a keen sense of alertness and analytical skills.
What We Offer
We offer a permanent contract, full-time employment with partial remote work options, electronic meal vouchers, RTT, complementary health insurance, and reimbursement of transport costs at 50%.
