QA Specialist

     

JOB DESCRIPTION:

GLOBAL COMPANY OVERVIEW
At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love.
With global headquarters in Chicago, USA, we serve people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. Our 114,000 colleagues are helping millions of people to live better and healthier, every day around the world. In South Korea, we’ve been helping people live fully for more than 30 years.

한국애보트 : 글로벌 헬스케어 기업 애보트의 한국 법인으로, 진단·의료기기·제약·당뇨 등 다양한 헬스케어 솔루션을 통해 한국 국민의 건강한 삶에 기여하고 있습니다. (사무실 위치 : 대치동)
애보트메디칼코리아 : 애보트의 심혈관·구조심장·전기생리 분야 의료기기를 담당하는 한국 법인으로, 혁신적인 의료 기술을 통해 환자의 삶의 질 향상에 기여합니다. (사무실 위치 : 역삼동)
애보트래피드진단 : 애보트의 신속진단 사업부로서 의료기기 및 체외 진단 시약을 생산하며 현장 진단 검사의 세계적인 리더 기업입니다. (사무실 위치 : 분당 정자동)
한국애보트진단 : COVID-19, 말라리아, 인플루엔자, HIV, 매독, 간염 등 다양한 감염 질환을 신속하고 정확하게 진단할 수 있는 체외진단 의료기기를 연구, 개발, 생산합니다. (사무실 위치 : 기흥)

Diagnostics

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Primary Function/Primary Goals/Objectives:

• Perform the quality test and inspection for Dx products imported according to the established test inspection procedures.
• Maintain accurate quality records and documentation files as per the procedures.
• Maintain the latest requirements for Operating and Test Procedures aligned to Core Diagnostics Policies and Procedures, and other Government Requirements to be used in import/distribution operations.
• Monitor/Adjust all of quality processes of commercial affiliates and warehousing documents for audit trails.

Major Responsibilities:

1. Perform/Support the quality inspection for incoming/releasing on labeling and finished goods to determine

conformance to the established specification.

2. Perform/Support Quality Control to assure all the results of inspection and/or testing as per the relevant

procedures.

3. Perform/Support Maintain the latest requirements for Operating and Test Procedures aligned to Core

Diagnostics Policies and Procedures, and other Government Requirements (Medical Device and IVDD Act) to

be used in import/distribution operations.

4. Perform/Support Quality Hold/Field Action/Product Information/Medical Reporting as per the relevant

procedures.

5. Perform/Support the KGMP preparation and renewal.

6. Perform/Support all applicable equipment are properly calibrated and maintained as per Core Diagnostics

Policies

7. Perform/Support NCR and CAPA for relevant procedures.

8. Perform/Support Distributor/Supplier evaluation and change control.

9. Perform/Support Document Change Control for LB/IFU/DMR and other quality processes.

10. Perform assigned training on time.

11. Perform other activities assigned and/or instructed by a direct supervisor.

Educations:

•  Minimum Bachelor’s Degree is required
•  Proficient in using MS office/Hancom and PC.
•  Quality system discipline or equivalent would be desirable.

Background:

•  Excellent interpersonal skills and ability to participate with others in projects and innovation
• Possess critical thinking skills and the forward-looking approach, receptive and adaptive to changes given the dynamic business environment
•  Ability to communicate and to present reports & ideas
•  Knowledge and experience of the quality control activity is desirable.
•  Basic knowledge of Medical Devices or IVD products is desirable.

Accountability/Scope:

•  Collaborate with internal/external stakeholders
•  Timely completion of work as per relevant procedures.
•  Complying with Abbott requirements and Government regulations.
•  Good Document Practice for Audit Trail

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CRLB Core Lab

        

LOCATION:

Korea > Ansan : 88 Sandan-ro, Danwon-gu

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable