모집부문 및 상세내용공통 자격요건 | ㆍ학력 : 대졸 이상 (4년)-이공학 계열 전공 |
| QA Design Assurance EngineerQA 0명
* 주업무 :
• Promotes the awareness of regulatory and customer requirements throughout the organization.• Remediation of current Design Control procedures and practices across sites to standardise to “best in class” design controls. Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.• Deployment of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams and relevant functions within the Business Unit.• Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze.• Support new test development and appropriate test method validation.• Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams.• Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.• Escalate where appropriate design control concerns/ issues in a timely manner to ensure project schedule maintenance.• Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). • Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.
지원자격 및 우대사항 | ㆍ경력 : 경력 8년 ~ 15년(과장, 차장, 팀원급)
* • Majored in Science, Engineering or Technology, plus 2-3 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA).
• Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem Solving would be beneficial.
• Excellent data analysis skills.
• Proven ability to work well as part of a team and on own.
• Excellent communication skills to support virtual project requirements.
• Clear demonstrated experience in working in a diverse cultural environment.
• Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
• Travel pending company policy, global and country regulations to Asia and Europe.
* Good command of English
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| 근무조건| ㆍ근무형태:정규직 | | ㆍ근무일시:주 5일(월~금) 오전 9시~오후 6시 | | ㆍ근무지역:(16943) 경기 용인시 수지구 광교중앙로296번길 4 골드리치안오피스텔(상현동) - 신분당선 상현 에서 200m 이내 |
| 전형절차
| 접수기간 및 방법| ㆍ접수기간:2024년 6월 17일 (월) 08시 ~ 2024년 6월 30일 (일) 24시 | | ㆍ접수방법:사람인 입사지원, E-mail / jiko01@kohuman.com | ㆍ이력서양식:자유양식(영문)
* 보내실 곳 : E-mail / jiko01@kohuman.com
* 문의하실 곳 : 고 재익 010 8636 5759
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| 유의사항| ㆍ학력, 성별, 연령을 보지않는 블라인드 채용입니다. | | ㆍ입사지원 서류에 허위사실이 발견될 경우, 채용확정 이후라도 채용이 취소될 수 있습니다. | | ㆍ모집분야별로 마감일이 상이할 수 있으니 유의하시길 바랍니다. |
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