외국계 의료기기 품질보증 전문가 모집부문 및 자격요건 모집부문 담당업무 자격요건 인원 의료기기 품질보증 전문가 [담당업무] · Management of quality system - Management of quality documentation (Quality Manual, Procedures, PMF, Local Language Label, etc) - ISO 13485/MFDS/Corporate audit - CAPA & Risk management - Supplier management - Quality release of repaired products · Post-market surveillance activities - Complaint handling and follow-up in Korea - Assess the reportability of global complaints and report foreign adverse events to MFDS - Field action including recall activity, quality hold, issue evaluation, etc - PMS data collection for license renewal and reevaluation · Compliance with MFDS requirements - Maintenance of KGMP certificates, including on-site audits and document audits - UDI registration and maintenance, and Monthly supply report - Track and follow up on the new regulations/requirements [자격요건] · Expected Areas of Competence - Competent English language skills (reading, writing, listening, and fluent speaking) - Comprehensive knowledge of MFDS regulations - Strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory authorities - Knowledge of medical device products (Implants and/or electronic devices) and regulations, and ability to interpret them - Ability to manage multiple projects - Responsible, professional, detail-oriented - Strong computer skills · Education/Experience Requirements - Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred - Minimum of 3-4 years of experience required in Quality Assurance - Certifications are an advantage, including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC [자격요건] -경력: 경력 3~13년 -학력: 대졸 -직무기술: 품질보증 -기타: 담당업무 >; 자격요건 참고 0 명 근무조건 고용형태: 정규직 급여조건: 회사내규 전형단계 및 제출서류 전형단계: 서류전형 >; 1차면접 >; 2차면접 >; 최종합격 추가 제출서류 이력서, 자기소개서 접수방법 접수방법: 인크루트 접수, 이메일 접수양식: 인크루트 이력서 기타 유의사항 입사지원서 및 제출서류에 허위사실이 있을 경우 채용이 취소될 수 있습니다. 00
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