Medical Device Assessor

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 Medical Device Assessor / ISO 13485 Lead Auditor.


Mediacal Device Assessor partners with clients in the Medical Device industry to improve the quality and safety of their business performance through the application of internationally recognized standards.


Tasks include:

  • Perform 3rd party onsite ISO 13485 (Medical Device) audits and MDD Technical file assessment for Italy and world-wide customer
  • Schedule and plan audit activity with customers
  • Interact 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
  • Document and report audit activities and results
  • Provide timely and accurate reviews of customer corrective action and closure
  • Maintain 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 experience in the Medical Device industry
  • ISO 13485 Auditor Certification is preffered
  • Working knowledge of ISO 13485
  • Working knowledge of ISO 14971, Medical Device Risk Management
  • Successful completion of training within Medical Device Directive and ISO 13485
  • Demonstration of excellent customer service skills
  • Ability to work independently and in teams
  • Very good communication skills in English and Italian
  • Good communication skills in Spanish or French will be an advantage
  • Commencement Date 

Starting date:


Negotiable. January 2018 is preferred.


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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