Lead Auditor/Assessor Medical

DNV GL Business Assurance Sweden AB

Local Unit & Position Description

Objective of the role:  

Manage, perform and deliver MDR and ISO13485 activities, assessment. 

Position Qualifications

Experience and knowledge in the following fields will be valued: 

  • Experience in the entire process of auditing medical device quality management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit and audit reporting. 
  • MDR qualification as Assessor by accredited NoBo is a plus 
  • ISO13485 qualification as Lead Auditor in an accredited program (e.g. under ACCREDIA) 
  • ISO9001 qualification as Lead Auditor under ACCREDIA 
  • Excellent working knowledge of standard ISO13485 and ISO9001 
  • Knowledge of Medical Device Regulation (EU) 2017/745 and of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 
  • Knowledge of specific harmonized standards (eg. EN ISO14971) 
  • Experience and competence in dental and orthopaedic Medical Device is a plus
  • Knowledge of Microsoft Office Applications 
  • Fluent in English & Italian 
  • Bachelor's Degree 

Competency Requirements:  

  • Minimum of four (4) years full time workplace in Medical Device field, of which at least two (2) years in testing, design, test validation, development, involving technical design 
  • Good interpersonal and organizational skills 
  • Ability to operate pro-actively and autonomously with an attention to detail 
  • Flexibility and an ability to function well under pressure 
  • An ability to manage, administer and develop data

Please submit CV in English. 

* Please note we may close this position earlier if a suitable candidate is found.

Company & Business Area Description

DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.

Equal Opportunity Statement

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!


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