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Engineer - Quality Management Job Details | B. Braun Group

Your key responsibilities:

• Qualification & Validation: Responsible make (Re)validation protocols/reports, coordinate with related department to commit with expected validation timeline. Involve and perform validation during Change control activity, involve and perform validation during Project execution. And ollow requirement of local/global SOP for (re)validation process and sharing ith with local team                                   
• Risk assessment: As team member for Process and Equipment risk analysis. Undertood and sharing risk analysis concept to related departments: Method, Action, Requirements…                                   
• Others tasks: Create/revise local SOP according to requirement in global SOP/ ISO/ regulations. Perform training/sharing SOP for Production/ QC/ IE to follow up. Make the training plan for new member/FSU and companion with them during development program                                  

What you will bring to the team:

• Education: Bachelor degree in Technical background. Nice to have knowledge and/or experience on ISO 13485, ISO 9001, ISO11135, ISO 11607.     
• Working Experience: Have at least 2-year working experience and knowledge in Validation and risk management/ Risk analysis method. Nice to have: Validation for Medical device manufacturing process.       
• Skills required: Good command in English, presentation and communication, MS Office, team work