제약 의료기기 QA부서 Design Assurance Engineer

▣ 채용 포지션 : QA부서 Design Assurance Engineer 8~15년 과차장급

Major Responsibilities:
• 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."

자격요건
• 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.

▣ 전형방법 : 서류전형>면접(1차/2차임원)>OFFER협의
▣ 제출서류 : 영문 이력서(필수) , 경력기술서 (MS워드 형식/ 자체양식가능, 포탈양식 불가능 )
▣ 제출방법 : ymlim@plus-hr.co.kr 로 이메일 접수
-. 최종연봉, 희망연봉 필히 기재
-. 첨부 표준이력서양식 사용 권장

▣ 마감일 : ASAP ( 서두르고 있으니 지원의사 있으시면 빠른 확인바랍니다. )
▣ 근무지 : 경기도 용인 본사