당뇨사업부 QA Specialist at Abbott Pediatrics

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

26 Apr, 26

Salary

0.0

Posted On

26 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Adverse Events Handling, Corrective Action, Preventive Action, Root Cause Analysis, ISO 9001, ISO 13485, Document Control, Training Management, Change Management, Risk Assessment, Cross-Functional Team Leadership, Curriculum Development, Supplier Quality Management, Internal Audit Management, Microsoft Office

Industry

Hospitals and Health Care

Description

JOB DESCRIPTION: ABOUT ABBOTT : Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Diabetes Division(ADC) : We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. PRIMARY FUNCTION : The incumbent will actively support the quality operations in Korea as part of the organization’s business objectives, reporting directly to the in‑country Quality Manager. The role is responsible for supporting the management and monitoring of key quality process performance, ensuring continuous compliance with internal quality policies, procedures, and global standards. This will be achieved through strict adherence to internal procedural requirements and by contributing to the development, implementation, and maintenance of local SOPs, work instructions, checklists, and other quality system documentation, where applicable. The incumbent will also support the monitoring of compliance activities, communicate procedural requirements to relevant stakeholders, coordinate and manage training related to quality system requirements, and assist in the execution of corrective actions where required, maintaining alignment with both MFDS regulatory expectations and the company’s global quality framework. MAIN / MAJOR RESPONSIBILITIES : Play a key role in facilitating the communication of Adverse Events (AEs) to the Korean Regulator (MFDS). Support the preparation and execution of KGMP audits (new, renewal), including coordination of documentation from manufacturing sites, review of audit materials, preparation of submission packages, and facilitation of internal alignment to meet MFDS expectations. Assist in the organization of audit schedules, pre‑audit readiness checks, and follow‑up activities. When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, support investigations & root cause analysis, supporting the development & implementation of appropriate corrective/ preventative actions. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates. Act as the main Document control and training admin for the local quality system, supporting the creation, revision, obsoletion, management of training assignment & periodic review of documentation. Support the evaluation & quality management of internal & external suppliers. Assist QA Manager Korea to manage the internal auditing program, including but not limited to the development of internal schedules, performance of process auditing activities, and efficiently support of resulting actions. Play a major role in the tracking and trending of quality department key performance indicators, to allow efficient oversight of the local quality system. The status report will include current projected completion dates and will be updated and published as required / when status changes. Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Support manufacturing site requests (e.g., quality holds, reworks, complaint product returns). The position will require the incumbent to build effective relationships with local departmental representatives, Regulatory body representative & Global counterparts. Proactively support direct management in the achievement of the organization’s business objectives. MINIMUM BACKGROUND / EXPERIENCE REQUIRED : Bachelor’s degree or equivalent (4-5+ years) in a QA Role within the Medical device, Pharmaceutical or related industry experience. Experience in the handling of adverse event for reporting purposes. Experience in corrective action & preventative action problem-solving methodologies, including root cause analysis. Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem. Strong Knowledge of ISO 9001 and especially ISO 13485 Standards is preferred. Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards. Experience in document control & training management. Knowledge of change management & risk assessment is preferred. Experience in leading and participating in cross-functional teams tasked with QA problem resolution. Experience in training curriculum development is preferred. Experience in external supplier quality management is preferred. Knowledge of internal audit program management. Proficiency in Microsoft Office software (i.e., Word, Excel, and PowerPoint). Ability to communicate fluently/effectively in spoken and written English 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: ADC Diabetes Care 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

The QA Specialist will support quality operations in Korea, ensuring compliance with internal policies and global standards. Responsibilities include managing quality processes, facilitating communication with regulators, and supporting audits and corrective actions.