Sr QA Specialist

ABOUT ABBOTT:

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 115,000 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.

JOB SUMMARY:

Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and Korea regulations.

RESPONSIBILITIES:

• Execution of Product Shiphold, Field Safety Corrective Actions as per instructions from Regional or Corporate office.
• Provision of training to employees on quality related documents and policies
• Support and be accountable for external, internal and supplier audit in Abbott Medical Korea and the follow-up remediation plan.
• Preparation of data for management review.
• Identifies quality system problems, provides recommendations and resolutions.
• Manages the document control for all procedures and quality records
• Ensures all the Procedures are in place and the appropriate personnel have been trained on them.
• Interacts on a periodic frequency with Supply Chain, Technical Service and Education function on all quality related matters.
• Provides support to ensure that product labeling activities meets local and corporate/OUS quality & regulatory requirements
• Ensures that any changes to the Corporate Quality Manual and the OUS Quality Procedures are interpreted and implemented with the local Country manual and procedures where applicable.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
• Prepare and  maintain KGMP Certifications and applicable Quality related certification in the region.
• Be involved in the Risk Management and conduct CAPA process
• Post Market Surveiliance/Complaint Handling
• Vigilance reporting to MFDS and follow up actions.
• KGMP certification and related all maintenance activities.

QUALIFICATIONS:

• Minimum of Bachelor’s degree. Equivalent education/work experience will be considered.
• Minimum of 6 years experiences as a QA in a Commercial Quality environment.
• Computer proficiency in Word, Excel and PowerPoint.
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Effective time management - well organized, able to set and reset priorities
• Strong oral and written communication skills.
• Detail and deadline oriented.
• Conversant in both written and spoken English.
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
• Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.

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