Lead Auditor Medical Devices

Are you a specialist in the medical or medical devices sector? Have you ever thought of using your specialism to contribute to the safety and performance of medical devices according to the European Medical Device Regulation? Are you a qualified auditor for Medical Devices or do you want to become one? Kiwa France is recruiting internal auditors or free-lance auditors specialized in the MDR (CE marking) and/or EN-ISO 13485 schemes for France and Belgium. Do you want to further build on your experience in an ambitious international company? Then you might well be Kiwa’s new Lead Auditor Medical Devices!

In the role of Lead auditor, you are responsible for performing audits on quality management systems of manufacturers and suppliers of active and non-active medical devices. You will perform audits at organizations according to the Medical Device Regulations (MDR) and the EN-ISO 13485 standard. In addition, you can perform technical documentation assessments for the related medical devices. Our clients range from highly innovative start-ups to large companies, both national and international with a wide range of medical devices.

After an extensive internal training program, you:

• Execute audits independently as a Lead auditor;
• Are 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.

 

When you have sufficient working experience with specific types of devices, you may also take up the role of Technical File reviewer in combination with auditing.

You want to take a new step in your career and are interested to further develop your knowledge and skills. You are ready to receive an internal training program to become qualified as Kiwa Lead auditor under the applicable regulations and standards. You get energy from contributing to the quality and safety of products. You can work independently as well as in a team and take ownership for your work. You have good communication skills, informing and reporting to stakeholders in a clear and timely manner.

For this position, we’d like you to bring these educational and personal skills:

 

• 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.

As an Auditor Medical Devices at Kiwa, you’ll hold 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,

Where you’ll work
In this role, 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 the 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. You will work for and report to the Country Manager of Kiwa France.

 

Interested in the role of Auditor Medical Devices? Apply now by clicking on the red application button to apply at Kiwa.

More information
Should you have any questions about this position at Kiwa, please contact Mrs. Marine DEBAUT, Business Developer Medical France, by phone +32 476 78 29 67 or by mail marine.debaut@kiwa.com.

 

We look forward to hearing from you!