QA Specialist

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.

• 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.

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.

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

•  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.

•  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

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