Design Quality Engineer

Job content

• Sound Engineer knowledge and experience in Medical devices
• Strong Knowledge in verification and validation summary documents.
• Experience in engineering memos and engineering rationale.
• Experience in Product transfer projects.
• Strong Knowledge in DCRM, sales & complaint data, risk management reports and any other technical documents related to design and manufacturing.
• Mentoring skills to guide the PD team on all design control documentation to ensure that the documentation is in accordance with the current design quality guidelines
• Strong Knowledge in regulatory documents including essential requirement checklist, standard evaluation documents etc.
• Experience in design change evaluation checklists for all labeling documents (eg: surgical technique guide, IFU, patient care guide..)
• Strong communication skills to Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
• Strong Knowledge in all other standard Design Quality related day to day activities related to design transfer and manufacturing processes.
• German proficiency will be added advantages.
  

• Degree Qualified ( Preferred biomedical or Mechanical ) with 5+ years relevant experience in Medical Devices Industry
• Ability to work on own initiative
• Flexible work ethic
• Excellent working knowledge of process excellence / QE tools such as PFMEA , SE , statistical analysis , SPC
• CAPA and RCI experience
• Excellent IT skill eg , experience in Minitab , excel reports