ISO13485 & MDR Auditor

仕事内容

Local Unit & Position Description

Responsibilities :

• Responsibility for achieving his/her own KPI-targets
• Efficiently and competently implement ISO13485 &MDD&MDR auditing and assessment work for clients based on the CE Directives, International standards, other applicable Regulatory Systems and DNV’s accredited certification program
• Ensure work execution with absolute independence and integrity at all times Contribute to the ongoing improvement of operational efficiency and effectiveness by means of the identification and pursuit with regards to audit processes and handling of information within the team and unit, facilitating the rendering of service also to other functions within the organization as required
• Organize and deliver projects, i.e. assessment, gap analysis, training and customer workshops, etc.
• Maintain assessor/auditor registration with DNV and other relevant authorities to work as a Lead Auditor at DNV
• Other issues as assigned by the line Manager
  
  

Position Qualifications

Qualifications:

• Relevant bachelor or higher degree related to medical science and medical device area
• Core discipline: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc.
• Minimum of 2-4 years’ experience must be in the design, manufacture, testing or use of the device in the medical device industry /laboratory/hospital, ideally 1-2 years of them in clinical medicine
• Good knowledge of CE Directives of MDD&MDR, ISO13485 standards and other product specification
• Auditing experience and registered QMS of CCAA auditor is preferable
• High Customer focus
• Good communication and teamwork skills
• Fluent in written and spoken English
• Take the higher the workload with willing to travel frequently
  
  

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!