Auditor MHS for IVD Instruments - Seoul, 대한민국. - TÜV SÜD

설명

Aufgaben

Working as part of a team of medical specialists in the area of In-vitro Diagnostic Instruments/Software, the role will entail conducting regulatory audits and reviewing documentation to support CE marking, worldwide regulatory regimes and quality management system certification to enable manufacturers, importers and distributors to meet their compliance obligations, help them to develop safe and effective devices and to enable them to sell their devices around the world. This role would suit an experienced auditor from the medical device industry with a strong working knowledge of in-vitro diagnostic medical devices and active medical devices.

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

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)

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

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

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

Qualifikationen

Bachelor's/ Master/ Ph.D/ Doctor Degree graduate – preference major: Software, biomedical, electronics, information technology, computer science or relevant engineering/science discipline

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

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

: 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)

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

Self-motivated / Being able to work with minimal supervision / Good communication – verbal and written / Good stress handling

Development engineer / Manufacturing engineer / QA / Test Engineer

Capacity for reading of legal documents or technical standards in English