Quality Assurance Specialist

il y a 2 jours


Massy, Île-de-France Sensome Temps plein

About Sensome

Sensome is a pioneering company that develops innovative sensor technology to transform medical devices and implants into connected healthcare solutions. Our mission is to revolutionize healthcare by providing cutting-edge technology that saves lives and prevents disabilities.

Job Summary

We are seeking a highly skilled Quality Assurance Engineer to join our multidisciplinary team. As a Quality Assurance Engineer, you will play a critical 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 and generate, review, and edit procedures and other applicable documentation.
  • Facilitate and participate in nonconformities resolution activities and 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, and manage and coordinate qualifications and evaluations of suppliers.
  • Support the manufacturing team in managing documents and records and collaborate with the regulatory team to ensure compliance with regulatory requirements.
  • Follow changes in the regulatory landscape and provide guidance and recommendations to the team.

Requirements

  • Master's degree in engineering or a related field.
  • Fluency in French and English (read, written, and spoken).
  • Minimum 3 years of experience in quality management/quality assurance in the medical device industry.
  • Methodical, pragmatic, good communication skills, positive, and open-minded.
  • Ability to work in a multicultural 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.

Benefits

  • Permanent contract.
  • Full-time job with partial remote work possible.
  • Electronic meal vouchers.
  • RTT.
  • Complementary health insurance + Advanced medical support platform.
  • Reimbursement of transport costs at 50%.

Join Sensome and be part of a cohesive team united by a shared vision.


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