QA Specialist at Abbott in Seoul, Seoul, South Korea

QA Specialist Location: Korea - Seoul 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