QA Specialist

     

JOB DESCRIPTION:

JOB PURPOSE AND SCOPE
Ensure compliance of Quality Management System in Abbott Vascular (Korea) operation and meeting local regulatory requirements. 
Efficient Quality Assurance Activities with the relevant functions. 
Fluent communication with all relevant functions including global team and Authority Competency such as MFDS etc. 
Accurate and Flexible interpretation of Quality Management System and Korean regulation. 
 
CORE JOB RESPONSIBILITIES 
1)    Support for preparing Management Review Meeting and Monthly Meeting as per OMS
2)    Support Internal/External Audit and KGMP certification
3)    Compliance documentation and record retention as per OMS.
4)    Monitor and Control the warehousing and distribution
5)    Handling Quality Hold-Stop Shipment etc.
6)    Handling the Complaints and AE, FSCA in Post Market Surveillance
7)    Support or Exception of CAPA Process
8)    Report the AE to MFDS and response to the requirement from MFDS.
9)    Control the training management of all employees and distributors as training coordinator.
10)    Manage the new/revised record for Distributors
11)    Manage the all quality document and record as per OMS requirement.
12)    Prepare KGMP certification and related all maintenance activities
13)    Control the local addendum labeling including UDI with corporate team
14)    Control the supplier management in generated divisional process of OMS
 
 
QUALIFICATIONS

• Good computer skill with proficiency with Microsoft applications and Adobe Professional.
• Good organizing, planning, verbal and written skills
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Excellent communication skills.
• Good English Skill.

     

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:AVD Vascular

        

LOCATION:Korea > Seoul : SamTan Building, 421 Youngdong-daero, Gangnam-gu

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:Not Applicable