[담당업무]

▷ 회사: 외국계 바이오 기업

▷ 회사위치: 경기도

▷ 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 Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO).
- Ability to work is a matrix organization where project deliverables are accountable to the Program/ Workstream Leader.

▷ Requirements 

- 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 organization. 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. 

▷ 상기 job opening에 관심 있으신 분께서는 아래 담당자에게 연락바랍니다. 

담당: 김종민 이사 (jmkim@hijob.co.kr******@*******.*** / 070-7126-1950)