Lead Auditor Medical Devices Specialist
il y a 1 mois
We are seeking a highly skilled and experienced Lead Auditor Medical Devices to join our team at Kiwa France. As a Lead Auditor, you will be responsible for performing audits on quality management systems of manufacturers and suppliers of active and non-active medical devices.
Responsibilities:- Perform audits independently as a Lead auditor;
- Be responsible for the audit activities of your customers;
- Maintain frequent contact with the customer concerning the audit activities and follow up;
- Act as a linking pin and maintain frequent contact with your customers, colleagues, external experts and contractors;
- Will travel approximately 30-60% of your time, both national and international.
- A PhD., MSc. or BSc. in a relevant engineering or sciences discipline, for example biomedical, electrical or mechanical engineering, pharmacy, physics, 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, which may be gained as part based of a quality and regulatory team within development or manufacturing;
- 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;
- You are based in France or Belgium and are entitled to work here;
- You are able and willing to travel.
We offer a challenging position in an internationally oriented, ambitious, expanding Notified Body organization. At Kiwa, we value your professional development and personal wellbeing. You'll be given ample opportunities to balance your working and private life by planning your hours flexibly. When it comes to our terms and conditions, we offer you a salary tailored to your professional competence and experience.
Interested in the role of Lead Auditor Medical Devices? Apply now by clicking on the red application button to apply at Kiwa.
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