Lead Auditor, In-vitro Diagnostics
GreenPowerMonitor, a DNV company
full-time
Posted on:
Location Type: Hybrid
Location: Hamburg • Germany
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Job Level
About the role
- Planning and Conducting international Audits under ISO 13485, MDR or IVDR and MDSAP
- Conducting Technical Documentation assessments per competence profile.
- Documenting Audit results per Accreditation / Designation requirements.
- Develop and support the company culture within the Audit department
- Responsible for reporting to the Audit Team Leader
Requirements
- An academic degree in Engineering or any Natural Science
- At least 4 years work experience in the design, manufacturing, testing or application of medical devices
- Knowledge of quality management system certification and regulatory requirements for CE-marking
- Good communication skills (German and English)
- Ability to initiate and maintain cross-cultural collaboration
Benefits
- A competitive compensation and benefit package
- DNV training and qualification program
- A professional community in a prestigious technological company
- Possibilities to work with interesting and challenging projects
- Access to an extensive competence network
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ISO 13485MDRIVDRMDSAPTechnical Documentation assessmentsquality management system certificationCE-marking
Soft Skills
communication skillscross-cultural collaboration