Design Quality Engineer
Design Quality Engineer :
- 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.
Qualifications
Education and Experience :
Essential :
- Degree Qualified ( Preferred biomedical or Mechanical ) with + 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
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