I. Job Function:
1. Lead risk assessment activity for medical plants:
- Take lead risk assessment activity from QM.
- Respond to create, supervise, and manage the risk assessment management file of medical plant.
- Respond to lead team to involve and do risk assessment of change controls, improvement projects and projects to meet
requirements with stakeholders
- Coordinate with stakeholders to executive the risk assessment management file.
- Moderation of all risk analysis team meetings.
- To create/revise the risk assessment documentations shall comply with ISO standards, Global documentations
2. Validation activity
- Input risk analysis for Validatio engineer during prepare validation
- Update risk analysis after validation activities
3. Project activity
- Coordinate with Regional and Global to executive the risk assessment projects, programs.
- Involve/perform relate tasks to risk analysis as risk assessment expert
- Other tasks
- Create/revise SOP Risk analysis
- Training SOP Risk analysis
- Training plan for new member (FSU)
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Direct Manager from time to time.
II. Job requirement
- Bachelor's Degree with 2 years of related working experience or Master's degree with 1 year of related working experience in risk management
- Requires working knowledge of technical or production field.
- Knowlegle in ISO 13485, ISO 9001, ISO 14971 is preferred
- Knowledge of root cause analysis or 5 whys analysis. Have experienct about FMEA method/ 5M + 1E during control deviation in production is preferred
- Good English
- Communication
- MS Office
- Presentation
- Team work
