Medical Devices Auditor - High Risk Software. Dutch speaking

BSI; Netherlands; Hybrid; EUR 70,000 - 88,000; Full time

Benefits offered by this job

27 days annual leave

Pension plan

Healthcare allowance

Company car

Job summary

BSI is seeking a Medical Devices Auditor (Client Manager) specializing in High Risk Software. The position involves travelling to sites across EMEA to assess quality management systems, supporting patient safety and regulatory compliance.

You will receive ISO 13485 Lead Auditor, MDSAP and MDR training, then progress to conducting audits solo or in teams, writing reports and coordinating with planning and delivery teams. A STEM degree and strong Dutch/English are required.

Qualifications

• 4+ years of hands-on experience in R&D, design, maintenance/testing or manufacturing.
• Experience with quality management systems in medical devices.
• University or technical degree in a related STEM field (BSc/MSc/PhD).

Responsibilities

• Receive ISO 13485 Lead Auditor, MDSAP and MDR training.
• Observe audits initially, then conduct audits individually.
• Conduct audits on site, remotely or hybrid, alone or in a team.
• Write reports and liaise with planning and delivery teams to manage clients and audit schedules.
• Complete other administrative tasks as required.

Skills

R&D experience

Design / design development

Maintenance / testing

Manufacturing / production

Education

STEM degree (BSc/MSc/PhD)

Tools

ISO 13485 Lead Auditor training

MDSAP training

MDR training

Job description

Medical Devices Auditor (internally known as Client Manager) - High Risk Software

We exist to create positive change for people and the planet. Join us and make a difference too!

Location: The Nethederlands- field-based, 70%-75% of travel required within EMEA

About the role

We’re looking for talented people to join our medical device auditor team. The role involves travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessment activities such as those related to UKCA and CE marking.

Responsibilities:

In the first six months of being a Client Manager, you will:

• Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)
• Initially observe how audits are conducted but then grow to conduct them on an individual basis

In a typical week after being fully trained, you will:

• Conduct an audit on site, remotely or hybrid, working alone or as part of a team
• Write up your reports and liaise with the planning team and delivery manager to manage your clients and audit schedule
• Complete other administrative activities as required

1) To be successful you need to have a minimum of 4 years hands on experience in one or more of the following areas:

• research and development
• design or design development;
• servicing, maintenance and or testing;
• manufacturing or production experience.

2) Covering a range of medical devices which could include:

• High Risk Software devices

3) Your experience will also include at least 2 years’ working with quality management systems.

4) You must have completed a university or technical college degree or equivalent in a related STEM subject (BSc, MSc or PhD) such as: Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, or Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics

5) Native or high level of Dutch and English

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 27-days annual leave, paid sick leave, bank holidays, pension plan, company car, healthcare allowance, paid maternity leave, paid paternity leave, paid parental leave, paid emergency leave, paid short-term care leave, paid bereavement leave, learning and development opportunities,and a wide range of flexible benefits that you can tailor to suit your lifestyle.

The salary for this position can range from€70,000 to €88,000 annually.

#LI-LH1 #LI-Onsite

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.