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 (QM)
Company:  B.Braun Vietnam Co. Ltd.
Job Posting Location:  VN-Hanoi (Thanh Oai Complex)
Functional Area:  Quality
Working Model:  Onsite
Requisition ID:  672

Job Purpose:                                             
Coordinate and Maintain all (re)validation activities for all processes of Plant.          

                                             

Tasks & Responsibility

1. 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
  • Follow requirement of local/global SOP for (re)validation process and sharing ith with local team                                   

 

2. Risk assessment           

  • As team member for Process risk analysis
  • As team member for Equipment risk analysis
  • Undertood and sharing risk analysis concept to related departments: Method, Action, Requirements…                                   

 

3. 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                                  

 

Qualification Requirements

1. Education                                                                                         

  • Bachelor degree in Technical background.                           
  • Nice to have knowledge and/or experience on ISO 13485, ISO 9001, ISO11135, ISO 11607.     

 

2. Working Experience                                                                                                    

  • Have at least 2-year working experience and knowledge in Validation
  • Risk management/ Risk analysis method                           

Nice to have:

  • Validation for Medical device manufacturing process.       

                    

3. Skills required:                                                 

  • Good command in English, Presentation and Communication
  • Communication
  • MS Office
  • Presentation
  • Team work    

                                        
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