QA Specialist

     

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE:

• Support post market activities and regulatory reporting
• Ensure compliance to corporate policies and any local regulatory requirements

 
MAIN RESPONSIBILITIES:

• Ensures that all activities are performed in compliance with quality system requirements.
• Responsible for management of complaint handling/adverse event reporting activities and ensuring timely and accurate regulatory reporting to Ministry of Food and Drug Safety (MFDS)
• Supports field actions/ product recalls and other post market surveillance requirements, where applicable.
• Provision of training to employees on quality related documents and policies, ensuring timely assignment of training and driving training compliance.
• Manage document control process for all local procedures and quality records
• Support change control process in response to new or revised regulatory requirements with guidance from line manager.
• Execution of product stop ships as per instructions from manufacturer or distribution Center.
• Preparation of quality metrics data for management review and coordinate meetings and follow up actions.
• Participate and coordinate in global or regional quality improvement projects/ initiatives
• Support and coordinate external and internal audits and the follow-up remediation plan.
• Responsible for supplier/ distributor evaluation and performance monitoring when required.

 
QUALIFICATIONS:

• Minimum of Bachelor’s degree in Science or related discipline. Equivalent education/ work experience will be considered.
• Master’s degree in Science or related discipline is a plus
• 3 years of working experience in a commercial Quality or related environment
• Computer proficiency in Word, Excel and PowerPoint
• Good interpersonal skills with the ability to build and maintain relationships and able to work with various stakeholders
• Effective time management
• Detail and deadline oriented
• Conversant in both written and spoken English
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges  

     

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:

EP Electrophysiology

        

LOCATION:

South Korea > Seoul : Dongyoung Munhwa Center, 337 Eonju-ro, Gangnam-gu

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable