Medical Devices Lead Auditor
il y a 4 semaines
We are seeking a highly skilled Medical Devices Lead Auditor to join our team at Kiwa France. As a Medical Devices Lead 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 on quality management systems of manufacturers and suppliers of active and non-active medical devices
- Ensure compliance with the Medical Device Regulations (MDR) and the EN-ISO 13485 standard
- Perform 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
- 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
- Minimum of 4 years experience in the medical device sector
- 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
Kiwa is an internationally oriented, ambitious, expanding Notified Body organization. We value your professional development and personal wellbeing. As a Medical Devices Lead Auditor at Kiwa, you will hold a challenging position in a rapidly growing team. 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.
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