Your tasks

1. Obtain the authorization of auditor/technical documentation file assessor in IVD (in-vitro diagnostic) device and active medical device areas from accreditation bodies by the target date through the provided training in English

2. Conduct the administrative work to support Team regardless of Korean job title, gender and ages (e.g. quotation, documentations for audit files, audit registration, certification, review of the audit files, and upload of audit files to the internal database system which are written in English)

3. Conduct the audit projects involving a business trip in domestic or oversea facilities, making the prompt decision with objective and impartial matter based on the objective facts, and reaching the agreement with the customers

4. Manage the customers as the key account manager to arrange the projects (including subcontracting with oversea experts in English if needed), to deal with the customer complaint, price negotiation, and to develop/maintain/expand the long-term relationship as right business partner

5. Continuously learn the updated medical device regulation as well as expanding the experience/ authorization additional area of medical devices and its associated standards in English in order to add the value to the customers

Your qualifications

1. Bachelor’s Degree or above / preference major: Software, biomedical, electronics, information technology, computer science or relevant engineering/science discipline

2. Experience: 4 Years Professional Experience in the field of health care products or related activities such as in manufacturing, R&D, testing laboratory and auditing of which:

2 years shall be in the area of Quality Management System

2 years in an area relevant for respective technology – IVD Instrument (IVT2010, IVS1008 and IVS1010) and IVS Software (IVS1009 assessment of software evaluation, verification validating testing data)

1 year work experience as test engineer in the area IEC61010-1, 61010-2-101, 60601-x + ISO/IEC 62304 testing experience at ISO/IEC 17025 accredited laboratory in a preference

3. Korean: native / English: good communication and writing skills (e.g. TOEIC score above 800)

4. Well organized / Self-motivated / Being able to work with minimal supervision / Good communication – verbal and written / Good stress handling / Capacity for reading of legal documents or technical standards in English

5. Development engineer / Manufacturing engineer / QA / Test Engineer Qualification

Additional Information

[Required Documents]

Korean resume & English resume

Korean self-introduction letter

English cover letter

**Please make one PDF file