Medical Device Quality Assurance Expert

il y a 1 semaine

Massy, Île-de-France Sensome Temps plein
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.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the effectiveness and compliance of our Quality Management System. This is an excellent opportunity to work with a multidisciplinary team of passionate individuals who share a common vision.

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 to identify and mitigate potential risks.
  • Develop, review, and edit procedures and documentation to ensure compliance with regulatory requirements.
  • Facilitate and participate in nonconformities resolution activities to ensure timely and effective resolution.
  • Support the planning and coordination of corrective and preventive actions, changes, deviations, and other quality-related activities.
  • Conduct internal and external audits to ensure compliance with regulatory requirements.
  • Perform product quality control, including incoming inspection and batch release.
  • Manage and coordinate qualifications and evaluations of suppliers to ensure compliance with regulatory requirements.
  • Support the manufacturing team in the management of documents and records.
  • Collaborate with the regulatory team to ensure compliance with regulatory requirements.
  • Stay up-to-date with changes in the regulatory landscape and provide guidance and recommendations to the team.
Requirements
  • Master's degree in a relevant field (e.g., engineering, quality assurance).
  • Fluency in French and English (written and spoken).
  • Minimum 3 years of experience in quality management/quality assurance in the medical device industry.
  • Methodical, pragmatic, and excellent communication skills.
  • Ability to work in a multicultural environment and as part of a team.
  • Ability to manage activities independently with a keen sense of alertness.
  • Ability to analyze, make informed decisions, and continuously improve.
What We Offer
  • Permanent contract.
  • Full-time job with partial remote work possibilities.
  • Electronic meal vouchers.
  • RTT.
  • Complementary health insurance and advanced medical support platform.
  • Reimbursement of transport costs at 50%.

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