QA Specialist Korea - Seoul Full time ㄴ 오늘 공고 31117072 직무명세서 PRIMARY FUNCTION / OBJECTIVE: • Support post market activities and regulatory reporting • Ensure compliance to corporate policies and any local regulatory requirements MAJOR RESPONSIBILITIES / ACCOUNTABILITY: • 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. EDUCATION, EXPERIENCE, KNOWLEDGE/SKILLS: • Required minimum formal education • Minimum of Bachelor's degree in Science or related discipline. Equivalent education/ work experience will be considered. • 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 • Preferred formal education: Master's degree in Science or related discipline is a plus • Minimum required professional experience: 3 years of working experience in a commercial Quality or related environment • Preferred professional experience: 4 years of working experience in a commercial Quality environment is a plus • Legal / Certification requirements: Local RA certificate KNOWLEDGE/SKILLS: • Language Requirements-Korean and English • Product Knowledge-Able to understand and comprehend product licenses to understand device operational principles • Quality System Knowledge-Basic ISO 13485 and local regulations related to QMS • Manufacturing Knowledge-Basic understanding of QMS processes • Business Knowledge-Able to understand and comprehend SOPs of Abbott Global Commercial Quality System Regulatory Knowledge-Able to comprehend and implement local regulations • Commercial Knowledge-Able to understand and comprehend SOPs of Abbott Global Commercial Quality System • IT Systems / Skills-Able to follow SOPs of Abbott IT related documents • Training / Certification-ISO 13485 principles The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. 직무 군 Operations Quality 디비전 EP Electrophysiology 지역 South Korea > Seoul: Dongyoung Munhwa Center, 337 Eonju-ro, Gangnam-gu 지역 추가 근무 형태 Standard 출장 Yes, 5% of the Time 의학적 감시 Not Applicable 특수 업무 Not Applicable
