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 an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results.Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.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.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!