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Lead Auditor - Active Devices

Lead Auditor - Active Devices

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Lead Auditor - Active Devices

Lead Auditor - Active Medical Devices

- Independent planning, implementation and documentation of unannounced and regular audits at medical technology manufacturers
- Careful support of customer projects, especially new customers, as the first operative contact
- Independent evaluation of technical documentation of medical products
- Readiness for intensive familiarisation with the standards ISO 13485, ISO 9001, MDR and MDSAP
- Support of other departments in ad-hoc projects
- Cross - departmental collaboration in projects for process improvement

- Successfully completed technical or scientific studies, e.g. B. Biomedical engineering, electrical engineering or a comparable subject
- At least four years of professional experience in the manufacturing environment of the health care sector, e.g. B. at a manufacturer of medical products
- Ideally experience as an auditor and in project management
- Technical product knowledge in the field of medical technology
- In-depth knowledge of quality management or regulatory affairs according to ISO 9001 and ISO 13485
- Independent, proactive and solution-oriented work in direct customer contact
- Routine handling of MS Office applications
- Fluent German and English skills
- Car driver's license
- Enjoy regular business trips at home and abroad (approx. 60% travel activity)