• ISO 13485 Lead Auditor

    Location IT-MB-Vimercate | FR-Saint Priest | ES-Madrid | ES-Barcelona
    Requisition ID
    Business Area
    Business Assurance
    Project Management
    Location Details
    Vimercate, Monza and Brianza, Italy
    Position Type
    Permanent employment
    Close Date (dd/mm/yyyy)
  • Local Unit & Position Description

    DNV GL Business Assurance Italy is seeking a ISO 13485 Lead Auditor for active (including software) or non-active medical devices, including orthopaedic and dental devices.


    ISO 13485 Lead Auditor works with customers in the Medical Device industry to audit the quality and safety of their business performance through the application of internationally recognized standards.


    Tasks include:

    • Performing 3rd party onsite ISO 13485 (Medical Device) audits for Italian and non-Italian customer
    • Planning of audit activity with customers
    • Interacting directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system
    • Leading the Audit Team
    • Documenting and reporting audit activities and results
    • Providing timely and accurate reviews of customer corrective action and closure
    • Maintaining appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed

    Position Qualifications

    • Bachelor's Degree in Biology, Chemistry, Electrical/Electronics, Medicine or other related fields
    • Minimum 4 years job experience in the Medical Device industry
    • ISO 13485 Auditor Certification is preferred
    • Working knowledge of ISO 13485
    • Working knowledge of ISO 14971, Medical Device Risk Management
    • Working knowledge and/or Successful completion of training within Medical Device Directive and ISO 13485
    • Knowledge of intended use of medical devices
    • Knowledge of relevant product standards in the assessment of medical devices
    • Knowledge of Medical Device business/technology
    • Demonstration of excellent customer service skills
    • Ability to work independently and in teams
    • Very good communication skills in English and Italian (both written and spoken)
    • Intercultural Communication Skills
    • Good communication skills in Spanish or French will be an advantage

    Starting date:




    Please submit your CV in English.


    Company & Business Area Description

    DNV GL is a global quality assurance and risk management company. Driven by our purpose of safeguarding life, property and the environment, we enable our customers to advance the safety and sustainability of their business.

    We provide classification, technical assurance, software and independent expert advisory services to the maritime, oil & gas, power and renewables industries. We also provide certification, supply chain and data management services to customers across a wide range of industries.


    Combining technical, digital and operational expertise, risk methodology and in-depth industry knowledge, we empower our customers’ decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.

    With origins stretching back to 1864 and operations in more than 100 countries, our experts are dedicated to helping customers make the world safer, smarter and greener.


    DNV GL is one of the world’s leading certification bodies. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries.

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