Design Quality Engineer

VIR Healthway

Warsaw, IN

JOB DETAILS
SKILLS
Corrective and Preventative Action (CAPA) Systems, Data Management, Document Management, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Laboratory Testing, Manufacturing, Manufacturing Methods, Manufacturing/Industrial Processes, Medical Equipment, Metal Manufacturing, Microsoft Excel, Plastics Manufacturing, Process Failure Mode and Effects Analysis (PFMEA), Product Lifecycle Management, Quality Engineering, Risk Management, Sales, Statistics, Technical/Engineering Design, Usability Testing, Validation Testing, Writing Skills
LOCATION
Warsaw, IN
POSTED
4 days ago
Required experience:
  • Experience in Medical devices
  • Strong Knowledge in verification and validation
  • Writing test protocol/Reports for Mechanical and Usability lab testing.
  • Experience in Product transfer projects
  • Metal and Plastic Manufacturing process & Techniques
  • Strong Knowledge in DCRM/sales & complaint data/risk management reports/technical
  • documents related to design and manufacturing
  • Exp. in Risk management Process (ISO 14971)
  • Exp. in Design control documentation
  • Strong Knowledge in regulatory documents
  • Design change evaluation checklists for all labeling documents
  • Strong Knowledge in other standard Design Quality activities related to design transfer and manufacturing processes
  • Experience ISO 13485 standard and FDA and MDD / MDR Requirements
Essential:
  • Process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC
  • CAPA experience
  • PLM & MS Excel

About the Company

V

VIR Healthway