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※ This position opening has been closed If you have any inquiry, please contact the consultant directly for more information. |
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| :: QA Specialist(미국지사 파견) :: | |
| Company Introduction | 국내 코스닥상장 의료기기회사 |
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| Job Description | - Documenting and reporting product or service quality level - Developing and implementing standards for inspection - Developing a workflow for product inspection - Direct and when necessary, perform internal audits of process, facilities, and documentation to assure compliance with internal procedures, FDA regulation, ISO requirements and other regulatory agencies - Communicating with other team members to solve problems - Following up with the appropriate channels when mistakes are found - Training other quality insurance members on all inspection process - Control and oversee maintenance of documentation involved in the Quality System - Direct and when necessary, perform analytical quality assurance tests and interpret the results - Participate in the operation of the CAPA and/or Training systems - Assist with writing, updating and implementing procedures and specifications |
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| Job Requirement | - The hired employee will be dispatched to USA office in Denver with working visa provided - 1+ years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role preferred - Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures - Demonstrated ability to participate in groups resolving active quality issues or process improvement activities - Excellent interperonal and written/verbal communication skills - Strong analytical skills, with demonstrated ability to assemble, analyze, and summarize quantitative data - Manufacturing process and software validation experience preferred - Good understanding of design control principles and quality standards of practice and federal quality regulations including ISO 9001, ISO 13485, and QSR/21 CFR Part 820 - ** The applicants must be eligible for US work visa application** |
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| Location | 해외|해외 | Degree Level | 대졸이상 |
| Career Level | [과장급][대리급] | ||
| No. of Recruitment | 0 | ||
| Salary | 협의 | ||
| Required Document | 국영문 이력서 | ||
| Others | - 원서 마감후 1차(서류) 합격자에 한하여 개별연락 - 제출된 서류는 일체 반환하지 않습니다. - 해외여행에 결격 사유가 없는 자 - 이력서에 연락처, 희망연봉 게재 |
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| Contact/Inquiry | 양혜원 / 이사 02-6281- 5015 yhw@nterway.com |
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