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한국애보트

당뇨사업부 QA Specialist(대리급)

51-300명
  • 공고소개
  • 주요업무
  • 자격요건
  • 채용절차
  • 기타안내
이 포지션에 합격해 입사하시면 리멤버에서 합격 보상금 50만원을 드립니다
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.

주요업무

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.

자격 요건

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

채용절차

1st interview : 실무자 2nd interview : 임원 3rd interview : 인사부 & 인적성 검사

기타안내

4대 보험 / 장기근속수당 / 야근수당 / 퇴직금 / 우수사원포상 / 포상인센티브제 / 인센티브제 / 캐주얼데이 / 생일선물 / 명절선물 / 리프레시 보건휴가 / 남성출산휴가 / 육아휴직 / 산전 후 휴가 / 포상휴가 / 포상휴가 휴가비지원 / 근로자의 날 휴무 / 창립일 휴무 / 경조휴가제 / 반차 연차 / 노트북 / 카페테리아 / 회의실 / 생활식비 지원 / 사내 동호회 운영 / 리더십 강화교육 / 직무능력향상교육 / 신규 입사자 교육(OJT) / 출퇴근 회사차량 있음 / 주차비지원 / 주차장제공 / 차량유류비지급 / 자녀학자금 / 본인 학자금 / 선택적복리후생 / 통신비 지원 / 단체 상해보험 / 의료비지원(본인) / 건강검진
이 포지션에 필요한 전문분야/기술
GMP
CAPA
SOP
회사 로고
한국애보트
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company logo
한국애보트

당뇨사업부 QA Specialist(대리급)

51-300명
직급/직책사원,대리
연봉협의
근무지서울특별시 강남구
경력4년~10년 차
학력학사 이상
마감일
채용 시 마감
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