Medical Devices Auditor — High-Risk Software (ISO/MDSAP)

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

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.