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[의료기기 기업] QA/RA Specialist [산후 대체 계약직]
외국계 치과재료 제조 유통사   2022-12-22
면접후 협의   4년제 대졸이상
서울송파   마감

1. 담당 업무


l Maintenance of existing product licenses

l KGMP certificate renewal

l Compliance with MFDS & Corporate QA requirements

l Management of internal/external KGMP audit/inspections as company representative.

l Document control: Device Master File, SOPs and Quality manuals

l Quality oversight of the storage and release testing of products

l Manage deviation and CAPA(Corrective Action Preventive Action)



2. 희망 경력










§  Prepare for the successful KGMP on-site audit by MFDS/NB

- Prepare for the successful KGMP renewal by MFDS/NB in every three years

- Communicate with manufacturing sites to get the required documents and dossiers on time

- Prepare/revise/control local DMR and SOP to ensure compliance with the Corporate and the MFDS requirements for Dentsply Sirona Korea operation

- Adverse events reporting

- Support product complaint handling and take appropriate actions to ensure overall Korea regulations


-Experience of UDI (unique device identifier), UDI database and deep knowledge of MFDS requirements

- Experience with the design and implementation of a UDI for medical device units  


-Label Verification: Ensure data accuracy between labels and master UDI data




3. 자격조건 



- 유관 경력 3년 이상

Experience in registering an implantable medical devices (Class3~4)

Fluent in English

4. 기타

- 산휴대체 <계약직> 임



 - 워드 양식의  국문/영문 이력서  각1부 (경력 기술서,,사진 유첨)


 적합도가 현저히 낮은 경우 연락 드리지 않을 수도 있음을 양해 바랍니다.


* 후보자는 헤드헌팅에 관한 비용이 없습니다.(고객사부담) 

◈ VISION 2010 경영 혁신 大賞 수상`

◈ 2010 한국컨설팅 대상 HR부문 대상 수상`

◈ ISO 9001:2008 인증 기업 


담당:  원경림 이사

유선: 02-6925-3341

무선: 010-2751-5485

메일: won@bbp.co.kr     


원경림   이사
02-6925-3341/010-2751-5485   won@bbp.co.kr