Medical Device Certification Specialist
4 weeks ago
This role is for medical device certification. The main responsibilities of this role are:
Key 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, 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
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Sick leaves policy/ Annual leaves policy)
- Medical benefits - Annual Health Check-up
- Pension and Insurance Policies – (Pension Insurance, Medical Insurance, Unemployment Insurance, Work related injury insurance, Supplementary Pension)
- Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
- Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Housing Fund, Lunch Policy)
- Profit Share/ Chinese New Year Bonus
*Benefits may vary based on position, tenure/contract/grade level*
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.
Requirements:- 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
- 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
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