Medical Devices Quality Assurance Expert

il y a 6 jours


Paris, Île-de-France MyMenopauseRx, LLC Temps plein
Job Summary

We are seeking a highly skilled Medical Devices Quality Assurance Expert to join our team at Kiwa France. As a Medical Devices Quality Assurance Expert, you will be responsible for ensuring the quality and safety of medical devices. You will work closely with manufacturers and suppliers to ensure compliance with the Medical Device Regulations (MDR) and the EN-ISO 13485 standard.

Key Responsibilities:
  • Ensure the quality and safety of medical devices.
  • Work closely with manufacturers and suppliers to ensure compliance with the Medical Device Regulations (MDR) and the EN-ISO 13485 standard.
  • Perform audits on quality management systems of manufacturers and suppliers of active and non-active medical devices.
  • Travel approximately 30-60% of the time, both nationally and internationally.
Requirements:
  • PhD., MSc. or BSc. in a relevant engineering or sciences discipline.
  • Experience with active or non-active medical devices, including implanting devices.
  • Software experience is highly valued.
  • A minimum of 4 years experience in the medical device sector.
  • A minimum of 2 years experience in Quality Management and Regulatory Affairs.
  • Experience with quality management systems and relevant laws and regulations for CE-marking.
  • Auditing experience related to the MDR and/or EN-ISO 13485 is considered an advantage.
  • French and English language skills are required, other language skills are valued.
  • Ability to work in a team and independently.


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