Field-Based Medical Devices Auditor | ISO 13485 & MDSAP

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

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.