바이오스펙테이터

Company Name: 일루미나 코리아 (유)

Address: 서울특별시 영등포구 여의대로 66 KTB 빌딩 14층

Type: Full-time Employee

Job Description:

Position Title:

QA Specialist, Korea 

Position Summary:

The QA Specialist is responsible for regulatory compliance of IVD products imported by Illumina Korea according to MFDS regulations and other relevant local regulations. This position is responsible for establishing

and managing the quality system of the company to ensure medical devices sold by Illumina Korea are handled in compliance with KGMP and the quality is managed throughout product importing and distribution process.

Tasks and Responsibilities:

•   Follow Medical Device Act, other relevant regulations, and internal compliance of global Illumina.

•   Follow quality policies and standards of Illumina Korea.

•   Manage 3PL warehouse tasks (i.e. incoming inspection, labeling process) and maintain the relative records.

•   Manage distributions following GSP compliance.

•   Manage the process and records for product import, storage, labeling and delivery to ensure sustained quality of products sold.

•   Obtain the quality data including product return, complaints, adverse events, recalls, risk management, CAPAs, NC, cooperate the data analysis and support the output.

•   Support the regulatory reporting, notifications, and registration amendments.

•   Arrange the foreign manufacturers’ inspection (Korea GMP) including the cooperation of site-audit based on requirements of Korea MFDS.

•   Provide compliance support to marketing, sales and FSE.

•   Support the local labeling and requirements based on Medical Device regulations.

•   Monitor local regulation changes and analysis and update to internal organizations about the impact.

•   Perform Regulatory reporting, notifications, registration amendments.

Preferred Education:

•   University graduate with major in Science (preferred biologics or chemical background)

Preferred Experience:

•   Min 2 years of experience of Quality Assurance and/or Regulatory Affairs in Medical Device industry or IVD industry

•   Good understanding in Medical device regulations and ISO 13485

•   Proficient in writing and speaking English

•   Good interpersonal, listening and communication skill.

•   Collaborative and a team player