ISO 13485 Auditor

Responsibilities

• Responsibility for achieving his/her own KPI-targets
• Execute ISO13485 and other audit tasks arranged by the company, and fully communicate with customers during the audit process
• Timely feedback to the company to audit the work of a variety of issues, and actively cooperate with the resolution of the problem
• Take the initiative to learn and continuously improve our professionalism and auditing skills to provide valuable advice and recommendations to our clients
• Understand customer needs during audits and provide feedback to relevant departments
• Actively participate in relevant training and witnessing work arranged by the company to maintain auditor qualification
• Other issues as assigned by the line Manager

Benefits

• 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.

Minimum 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 4 years' experience must be in the design, manufacture, testing or use of the device in the medical device industry/laboratory/hospital
• Auditing experience and registered QMS of CCAA auditor
• Experience in other Notify Body is preferable
• Good communication and teamwork skills
• Fluent in written and spoken English
• Willingness to take on a higher workload with frequent travel