QM Engineer (Risk Analysis)

• Bachelor's Degree with 2 years of related working experience or Master's degree with 1 year of related working experience in risk management 

• Require 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

• Competitive salary and attractive annual bonus 

• Guaranteed 13th month salary 

• Company health insurance 

• Responsibility allowance 

• Service award 

• Company canteen or lunch allowance  

• Company shuttle bus

• Exciting company engagement activities 

Are you a Quality Management Engineer passionate about quality management? If so, this opportunity could be for you! Join us in Hanoi at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! 

As a Quality Management Engineer at B. Braun you will play a vital role in leading risk assessment activity for medical plants

Your key responsibilities:  

• 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.
• To create/revise the risk assessment documentations shall comply with ISO standards, Global documentations
• Validation activity: Input risk analysis for Validation engineer during prepare validation. Update risk analysis after validation activities
• 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
• Create/revise/ Training SOP Risk analysis