61 Responsibility for achieving his/her own KPI-targets
61 Efficiently and competently implement ISO13485 & IVDR auditing and assessment work for clients based on the CE regulation, International standards, other applicable Regulatory Systems and company’s certification program
61 Ensure work execution with absolute independence and integrity at all times
61 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
61 Organize and deliver projects, i.e. assessment, gap analysis, training and customer workshops, etc.
61 Maintain assessor/auditor registration to work as a Auditor & Assessor
61 Other issues as assigned by the line Manager

Qualifications:
61 Relevant bachelor or higher degree related to medical science and medical device area. Core discipline: biology or microbiology; chemistry or biochemistry, medical technology, medicine and clinic practice, Biomedical science, computer and software technology; electrical, electronic, mechanical or bioengineering etc.
61 Minimum of 4 years experience must be in the design, manufacture, testing or use of the device in an In-Vitro diagnostic medical device related industry, academia or hospital environment, ideally IVD devices Audit and Assess experience in a notified body.
61 Auditing experience and registered QMS of CCAA auditor is preferable
61 High Customer focus
61 Good communication and teamwork skills
61 Fluent in written and spoken English
61 Take the higher the workload with willing to travel frequently