ISO13485 & MDD & MDR Auditor

Location CN-Shanghai
Requisition ID
Business Area
Business Assurance
Posting Position Type
Permanent Employee

Local Unit & Position Description

- 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 DNVGL'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 DNVGL and other relevant authorities to work as a Lead
Auditor at DNVGL

- Other issues as assigned by the line Manager

Position 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 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.

Equal Opportunity Statement

DNV GL 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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