DNV

Lead Auditor Medical Devices

DNV  •  Hamburg, DE (Hybrid)  •  5 months ago
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Job Description

Your primary tasks will include:

  • Planning and Conducting international Audits under ISO 13485, MDR 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


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.

  • 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.

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About Life Sciences

We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.

DNV

About DNV

DNV is the independent expert in risk management and assurance, operating in more than 100 countries. Through its broad experience and deep expertise DNV advances safety and sustainable performance, sets industry benchmarks, and inspires and invents solutions.

Whether assessing a new ship design, optimizing the performance of a wind farm, analyzing sensor data from a gas pipeline or certifying a food company’s supply chain, DNV enables its customers and their stakeholders to make critical decisions with confidence.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.

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Industry
Government & Public Safety
Company Size
10,000+ employees
Headquarters
Høvik, NO
Year Founded
Unknown
Website
dnv.com
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