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Lead Auditor In-vitro Diagnostics
vor 18 Stunden
About Us
We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.
As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.
About The Role
Your primary tasks will include:
- 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
What we offer
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
About You
- 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
Please note that we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
