Field Medical Devices Auditor — Travel, Global Standards & Impact

BSI; Nederland; On-site; 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 paternity leave

Paid parental leave

Learning and development opportunities

Job summary

BSI is seeking a Medical Devices Auditor (Client Manager) to travel across EMEA, performing quality management system audits for high-risk software and devices. You will train in ISO 13485 Lead Auditor, MDSAP and MDR, then audit on-site, remotely or in hybrid settings.

Requirements include 4+ years in relevant areas, 2+ years with quality management systems, and a STEM degree. Dutch and English proficiency is essential.

Qualifications

• Minimum 4 years hands-on experience in one or more of the listed areas.
• At least 2 years working with quality management systems.
• University or technical college degree in a related STEM subject (BSc, MSc or PhD).
• Native or high level Dutch and English.

Responsibilities

• Conduct on-site, remote or hybrid audits as required.
• Write reports and coordinate with planning and delivery teams.
• Support audit schedule management and client liaison.
• Engage in training in ISO 13485 Lead Auditor, MDSAP and MDR.

Skills

R&D experience

Maint/Testing experience

Manufacturing exposure

Quality management systems

English (advanced)

Dutch (native/high)

Education

STEM degree

Tools

ISO 13485

MDSAP

MDR knowledge

Job description

BSI is seeking a Medical Devices Auditor (Client Manager) to travel across EMEA, performing quality management system audits for high-risk software and devices. You will train in ISO 13485 Lead Auditor, MDSAP and MDR, then audit on-site, remotely or in hybrid settings.

Requirements include 4+ years in relevant areas, 2+ years with quality management systems, and a STEM degree. Dutch and English proficiency is essential.