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Senior Engineer Validation and Quality

Posted on Jan 9, 2020 by Michael Bailey Associates - UK Contracts

Zürich, Switzerland
Engineering
3 Feb 2020
Annual Salary
Contract/Project

Main Responsibilities

  • Work closely with R&D and Manufacturing Engineering on Design and Process Validations and Qualification of Equipment
  • Evaluate, review and approve Validation and Qualification plans and reports and Risk files
  • Responsible for complete handling of material returned from the field (RMA) for complaint investigations
  • Analyse and report trends and statistical data from investigations with R&D and company management
  • Responsible for providing support and communication with external customers to resolve quality issues and other related product concerns

Your profile

  • Bachelor or Master's Degree in Electrical Engineering or similar education
  • 3 years of experience in a similar position in a highly regulated environment, preferable in Med-Tech industry
  • Good knowledge of the Med-Tech Industry regulations (ISO/FDA/GMP)
  • Experience in failure investigations in soft- and hardware applications
  • In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
  • Experience in Project Management
  • Experience with CAPA processes
  • Experience in communication with customers and suppliers
  • B1 German B1 English

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 824678712

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