Medical Devices Auditor - Active, Software

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

Benefits offered by this job

27 days annual leave

Pension plan

Company car

Healthcare allowance

Paid maternity leave

Paid parental leave

Flexible benefits

Learning and development opportunities

Job summary

BSI’s Medical Devices Auditor role (Client Manager) is field-based across the EMEA region, with 70-75% travel. You will assess quality management systems to support patient safety and regulatory compliance, auditing against ISO 13485 and related schemes such as MDSAP and MDR.

The successful candidate will have at least four years' hands-on experience in R&D, servicing or manufacturing and at least two years in quality management, plus a STEM degree and fluency in Dutch and English.

Qualifications

• Minimum 4 years hands-on experience in one or more of: research and development, servicing/maintenance/testing, manufacturing or production experience.
• At least 2 years working with quality management systems.
• University or technical college degree in a related STEM subject (BSc, MSc or PhD).

Responsibilities

• Travel to various locations to assess quality management systems and support patient safety and regulatory compliance.
• Conduct audits on-site, remotely or hybrid, working alone or as part of a team.
• Write up reports and liaise with planning and delivery teams to manage clients and audit schedules.
• Complete other administrative activities as required.

Skills

Quality management systems

Audit experience

English proficiency

Dutch proficiency

Education

BSc/MSc/PhD or equivalent in STEM

Tools

ISO 13485 Lead Auditor training

MDSAP

MDR (Medical Device Regulation)

Job description

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

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

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

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

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
• 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.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognised 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.