Lead Auditor Medical Devices

Korte introductie: Are you an experienced Lead Auditor in Active Medical Devices and looking for more team work and a better work/life balance? Join Kiwa Dare: a growing Medical Notified Body in the Netherlands Kiwa Dare B.V. certifies active medical devices and software (NB 1912). We are an ambitious international company, where we work together on safe products and our prosperous future. Over de functie:
Kiwa Dare is a Notified Body since 2015, that already received its MDR-designation in 2019 (as first Dutch Notified Body). This means that almost all the work is targeted towards new clients under the MDR, leading to an intensive learning environment and ample possibilities to contribute to the development of our organization.

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

After a warm welcome, an intensive training and onboarding 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,
- Will travel approximately 40-60% of your time, mainly Benelux.

Wat verwachten wij van jou?:
You want to take a next step in your career and you are interested to further develop your knowledge and skills. You get energy from working in a scale-up unit, where we work together on the development of our organization. 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 minimum of 2 years auditing experience related to the MDR and/or EN-ISO 13485,
- 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 medical devices,
- Software and/or AI experience is highly valued,
- A minimum of 4 years’ experience in the medical device sector,
- English language skills are required,
- Dutch is highly valued,
- You are able and willing to travel.

As an Auditor Active Medical Devices at Kiwa, you’ll hold a challenging position in an internationally oriented, ambitious, expanding Notified Body organisation. At Kiwa, we value your professional development and personal wellbeing. You’ll be given ample opportunities to balance your working and private life.

Wat zetten wij daar tegenover?:
When it comes to our terms and conditions, we offer you a salary range between € 4.500,00 and € 5.500,00 gross a month based on a 40 hour workweek (tailored to your professional competence and experience).

There is a possibility to work part-time and you will enjoy 37 vacation days among many other benifits.

**Where you’ll work**
In this role, you will work at the customers premises, partly from our loation in Woerden and partly from home. You will be part of the Medical Devices team: a growing team with highly qualified and driven medical device professionals. You will report to Esther Brandsen, Team Leader of the Notified Body.

**More information**
Should you have any questions about this position at Kiwa, please contact Esther Brandsen, phone +31 6 22988444. In case you have any questions about the procedure you can contact Mieke Dunning, HR Manager, phone +31 6 25252506.

We look forward to hearing from you