Senior Lead Auditor Active Medical Devices

Are you curious and passionate about ensuring the safety of medical devices? Do you thrive in a collaborative, energetic, and customer-focused environment? Kiwa Dare Woerden, the first Dutch Notified Body for MDR, is expanding and seeking dedicated Senior Lead Auditors to join us on this exciting journey.

Overview

Kiwa Dare Woerden is a leading Notified Body (NB 1912) for active medical devices, designated in 2019 as the first in the Netherlands for MDR. We specialize in serving SMEs, with over 60% of our clients involved in software (SaMD) and/or AI.

As a Senior Lead Auditor, you will prepare and conduct audits on the quality management systems of manufacturers of active medical devices. You will ensure compliance with the Medical Device Regulations (MDR) and/or ISO 13485 standards during audits and you support with the training and development of junior auditors.

What the role offers:

• A supportive energetic team environment and an intensive training and onboarding program
• Opportunities to work with innovative SMEs
• A chance to contribute to sufficient and safe medical devices on the market
• We care about our people and with 70% of our clients in the Netherlands, we can ensure a good work/life balance
• Our Process Managers assist you with client details and audit planning

As a Senior Lead Auditor, you will:

• Independently execute audits as a Lead Auditor (MDR and ISO 13485)
• Maintain regular communication with clients regarding audit activities and follow-ups
• Support trainees and junior auditors in their development
• Work closely with clients to improve their processes
• Support our growing organization with your expertise, which may include additional roles

Your profile:

• You are excited to join a scale-up team where teamwork and contributing to organizational growth are integral to our culture.
• You possess strong communication skills, effectively informing and reporting to stakeholders in a clear and timely manner.
• You have several years of experience in a MDR Notified Body as Lead Auditor Active Devices
• Software experience;
• Proficiency in English is required, and Dutch language skills are highly valued.
• You live in the Netherlands and are able and willing to travel for 3-4 audits per month

As an Auditor Active Medical Devices at Kiwa, you’ll hold a challenging position in an internationally oriented, ambitious, expanding Notified Body organization. At Kiwa, we offer you a salary tailored to your professional competence and experience and the possibility to work part-time. To ensure a great fit with our team, we conduct a personal assessment as part of the selection process.

Qualifications:

• Job satisfaction! You will be part of an enthusiastic and motivated team, working together on the most challenging projects;
• A gross monthly salary of at least €4.000 and up to €6.900 based on a full-time contract;
• 37 days off, ensuring a good work-life balance;
• 8% holiday pay, mobility budget, phone, and laptop;
• Benefit budget of 4%: choose between extra time off or additional salary;
• Opportunities for education and training to support your personal growth;

About Kiwa

Our experts are engaged worldwide in testing, inspection, and certification (TIC), supplemented by training, consultancy, and data services. With a heart for people and our planet, we work together to improve the quality, efficiency, health, safety, and sustainability of products across various industries. You can be a part of this. Shape your career at Kiwa, and we will provide the tools and opportunities for you to carve your own path. All this in an open and friendly environment where trust comes first.

Description of the team

In this role, you will work at the customers premises, partly from home and one- two times per month in Woerden. You will be part of the Medical Devices team: a growing team with highly qualified and driven professionals. You will report to Esther Brandsen, Team Leader of the Notified Body.