Overview
In this field-based role, you will travel across the EMEA region to assess quality management systems for medical devices, supporting patient safety and regulatory compliance. You will train in ISO 13485 Lead Auditor, MDSAP, and MDR, then conduct on-site, remote, or hybrid audits. You’ll write reports and coordinate with planning and delivery teams to manage audits and clients. This role is pivotal to maintaining compliance across organics/chemistry/pharma and tissue domains, contributing to safer products and regulatory confidence. A strong German and English capability underpins global collaboration and impact.
Leistungen / Benefits
- flexible working hours
- 30 days annual leave
- life insurance
- company car or car allowance
- paid maternity leave
- parential leave
Verantwortungsbereiche
- Travel to client sites within EMEA to conduct audits
- Perform on-site, remote, or hybrid audits individually or in teams
- Write audit reports and coordinate with planning and delivery teams
- Manage audit schedules and client relationships
- Handle administrative tasks as needed
Zentrale Anforderungen
- 4 years hands-on experience in R&D/design/servicing/manufacturing or related areas
- Experience with Organics/Chemistry/Pharma or Human Animal Tissue devices
- 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 of German and English
- strong communication and report writing
- travel readiness and adaptability
- problem solving and attention to detail
- ISO 13485 Lead Auditor training
- MDSAP
- MDR
Medical Devices Auditor - Organics. German speaking (m/f/x) in Oldenburg Arbeitgeber: BSI Group
BSI ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, in einem dynamischen und internationalen Umfeld zu arbeiten, während sie einen positiven Einfluss auf die Gesellschaft ausüben. Mit flexiblen Arbeitszeiten, kontinuierlicher Weiterbildung und einem starken Fokus auf Teamarbeit und persönliche Entwicklung fördert BSI eine inklusive Unternehmenskultur, die Innovation und Zusammenarbeit schätzt. Die Position des Head of AI Global Quality & Accreditation ermöglicht es Ihnen, als Branchenexperte zu agieren und aktiv zur Gestaltung von Richtlinien und Standards im Bereich Künstliche Intelligenz beizutragen.
