天津招聘

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 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

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

Driven by our purpose of safeguarding life, property and the environment, DNV enables organisations to advance the safety and sustainability of their business. We provide classification and technical assurance along with software and independent expert advisory services to the maritime, oil & gas and energy industries. We also provide certification services to customers across a wide range of industries.

DNV is the independent expert in risk management and assurance, with almost 12,000 employees 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 a world-leading provider of digital solutions and software applications with focus on the energy, maritime and healthcare markets. Our solutions are used worldwide to manage risk and performance for wind turbines, electric grids, pipelines, processing plants, offshore structures, ships, and more. Supported by our domain knowledge and Veracity assurance platform, we enable companies to digitize and manage business critical activities in a sustainable, cost-efficient, safe and secure way.