Jobid: 3200655110 (0.11)
Overview
In this role you help ensure patient safety and regulatory compliance by auditing medical device quality systems across Europe, the Middle East and Africa. You will be trained in ISO 13485 Lead Auditor, MDSAP and MDR, then progressively conduct audits on-site, remotely or in mixed settings. You work with cross-functional teams to plan, report and schedule audits, contributing to BSI’s mission of improving lives and trust. A global, field-focused role offers diverse medical device challenges and growth. You will travel broadly and shape critical conformity assessments.
Arbeidsvoorwaarden / Benefits
- 27 days annual leave
- paid sick leave
- pension plan
- company car
- healthcare allowance
- paid parental leave
Verantwoordelijkheden
- Receive training in ISO 13485 Lead Auditor, MDSAP and MDR
- Observe audits initially, then conduct audits independently
- Audit on-site, remotely or in hybrid setups
- Write audit reports and coordinate with planning team and delivery manager
- Manage clients and audit schedules; perform related administrative tasks
Belangrijkste vereisten
- minimum 4 years hands-on experience in design, development, servicing/maintenance/testing, manufacturing or production
- at least 2 years’ experience with quality management systems
- university or technical college degree in a related STEM subject (BSc, MSc or PhD)
- native or high level proficiency in Dutch and English
- ability to travel 70-75% within EMEA
- ISO 13485 Lead Auditor training
- MDSAP
- MDR (Medical Device Regulation)
- ability to conduct audits (on-site/remotely/hybrid)
- conformity assessment activities for UKCA and CE marking
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