Engineer - Quality Management (Risk Analysis)

4 days ago


Hà Nội, Vietnam B. Braun Medical Inc. Full time

Job Description

You’re an important part of our future. Hopefully, we're also a part of your future At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
- Engineer - Quality Management (Risk Analysis)

**Company**:B.Braun Vietnam Co. Ltd.

**Job Posting Location**:VN-Hanoi (Thanh Oai Complex)

**Functional Area**:Quality

**Working Model**:Onsite

**Requisition ID**:1337

**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

**4. 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



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