QA Specialist

Are you a QA passionate about Medical products? If so, this opportunity could be for you! Join us in at B. Braun Korea, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!As a QA Specialist at B. Braun you will play a vital role in ...Medical Device Quality Assurance1. Responsible for post-market surveillance activities for Medical device in B. BraunProcess the adverse event occurred in the field incl. reporting to local authority andrelevant manufacturer and Global Safety Officer.Report serious adverse event from overseas to local authorityManage field action regarding product recall/correction including report to MFDSManage the product complaints incl. reporting to local authority and manufacturers, communication with customers etcProvide the complaint/vigilance training to relevant stakeholders and internal employees as planned2. Ensure product quality and performance of product groups in compliance with Medical Device law and Corporate QMS.Conduct self-audit and supplier audit as plannedConduct inspection for product release and Block managementMaintain the Korean label and inserts (IFU, eIFU) in line with product registration and local regulations.Perform inspection for second-hand medical device releaseCoordinate with 3PL (3rd Party Logistics) to maintain high quality of imported medical devicesCollaborate with internal stakeholders to pursue alignment regarding companyprocesses and policy for the quality of medical devices3. KGMP maintenanceRenewal of KGMP certification when requiredKGMP certification when site been added/modified, if required.Establish, maintain and implement quality management system incl. processes and records in compliance with KGMP and corporate QMS.What you will bring to the team: ExperienceMinimum 3-6 years QA or relevant experience in healthcare or medical device industry preferred.Multinational company experience preferredSpecific knowledge /skillsCommunication and interpersonal skillsGood command of spoken and written EnglishKnowledge of the quality system of Medical device and related local regulations.Ability to work under competing priorities and to work cross functionallyBenefitsHealthcare 산업군 내에 경쟁력 있는 Benefit 제공선택적 근무 제도, 조기 퇴근제 및 재택 근무제 운영영Flexible Benefit 수당 (복지카드 제공)통신비 지원생일 상품권 제공건강검진 제공경조사금 및 휴가자녀학자금 (고등학교, 대학교)장기근무 포상