Medical Devices Auditor
il y a 4 semaines
We are seeking a highly skilled Medical Devices Auditor to join our team at Kiwa France. As a Medical Devices Auditor, you will be responsible for performing audits on quality management systems of manufacturers and suppliers of active and non-active medical devices.
Key Responsibilities:- Perform audits at organizations according to the Medical Device Regulations (MDR) and the EN-ISO 13485 standard.
- Conduct technical documentation assessments for related medical devices.
- Act as a linking pin and maintain frequent contact with customers, colleagues, external experts, and contractors.
- Travel approximately 30-60% of the time, both nationally and internationally.
- A PhD., MSc. or BSc. in a relevant engineering or sciences discipline, such as biomedical, electrical or mechanical engineering, pharmacy, physics, or information technology.
- 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.
- French and English language skills are required, other language skills are valued.
As an Auditor Medical Devices at Kiwa, you'll hold a challenging position in an internationally oriented, ambitious, expanding Notified Body organization. We value your professional development and personal wellbeing. You will work for Kiwa France, based in Alixan, near to Valence, but you will have the flexibility to work at home most of the time for reporting activities and technical file assessment.
You will be part of the Kiwa Medical Devices team which is growing rapidly and you will be cooperating with colleagues internationally. If you are interested in this role, please contact Marine DEBAUT, Business Developer Medical France, by phone or by mail.
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