◎ Position:
계약직 1
경력2년~경력10년
주요직무
"The Change Coordinator will play a pivotal role in managing change control activities within the centralized Change Control Board (CCB). The position ensures the effective generation, routing, tracking, and documentation of all changes while supporting regulatory compliance (IVDR) and adherence to the QMS policies and procedures to ensure on-going compliance and continuous improvement. The Change Coordinator will act as a liaison between stakeholders and the CCB, maintaining accurate documentation, performing impact assessments, and supporting decision-making with detailed reports and dashboards. The position reports to the Quality Project Manager and the role is based in Galway.


- Change Request Management: central point of contact for change requests in Agile PLM.
- Track and monitor changes through all Agile stages, ensuring timely progression.
- Coordinate the review and approval of CRs and COs with internal teams and CCB members.
- Develop and maintain dashboards, status reports, and metrics to monitor change control progress.
- Analyze change trends and provide insights to improve process efficiency.
- Liaise with cross-functional teams (Regulatory Affairs, Quality, R&D, Manufacturing) to align on change strategies.
- Ensure all stakeholders are informed of change progress and outcomes.
- Responsible for maintaining the QMS documentation program and also responsible for the control and distribution of records and overseeing the implementation of quality documents.
- Review and coordinate to ensure that all submitted documents meet the standards and requirements of the QMS. Approve administrative changes to controlled documents for Quality Assurance Team.
- Arranging documents to take effect and inform involved personnel to ensure all document changes are implemented in a timely manner.
- Standardize the writing of document records and the requirement for review and approval. Provides guidance on format, style and architecture of documents to enhance standardisation and clarity and to minimize unnecessary updates.
- Assist in the drafting, approval and distribution of other quality system documents and promote the consistency of quality management.
- Participate and support internal and external audits across the Business Unit (BU). " "

자격요건
- Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, Engineering, or a related field.
- 2 years of experience in change control, quality assurance, or document control in a regulated industry.
- Hands-on experience with Agile PLM or equivalent change/document management systems.
- Strong understanding of IVDR (In Vitro Diagnostic Regulation) requirements.
- Excellent organizational and time management skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Strong written and verbal communication skills.


Preferred Qualifications
- Experience creating dashboards, generating reports, and performing data analysis to track change control metrics.
- Knowledge of Tableau, Power BI, or similar tools for data visualization is a plus.
- Prior experience working with global regulatory requirements in addition to IVDR.
"


〔 전형절차 〕 서류전형 - 1차면접 - 2차면접 - 최종합격
〔 제출서류 〕 이력서 (자기소개서 및 경력기술서 포함)
〔 지원방법 〕 e-mail 접수

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