- 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
경력 및 자격요건
- 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**
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
