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Electrical - Engineer & Validations (Medical Device)

Location: Zürich, Switzerland Salary: competitive
Sector: Quality Assurance (QA) Type: Contract

Electrical - Engineer & Validations (Medical Device) m/f

For my client, part of a global Medical Device Manufacturer, I am currently looking for a specialist in Electrical Engineering, managing Complaint investigations, FMEAs and supports Projects related to Manufacturing, Validation and Process improvement.

  • Location: Central Switzerland
  • Duration: minimum 6 months, with potential extension
  • Departments: Quality Management/Engineering
  • Activities: Technical Complaint Investigations, Validations, Process improvements

Electrical - Engineer & Validations

Main Responsibilities

  • Responsible for Root Cause Analysis and complaint investigations for medical soft- and hardware applications
  • Evaluate, review and approve Validation and Qualification plans and reports and Risk files
  • Responsible for complete handling of Electrical and mechanical parts returned from the field for complaint investigations
  • Analyze and report trends and statistical data
  • Responsible for providing support and communication with external customers to resolve quality issues and other related product concerns

The profile

  • Bachelor or Master's Degree in Electrical Engineering or similar education
  • 2-3 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech or related industry
  • Good knowledge of Industry regulations (ISO13485/ FDA 21CFR820 / GMP) or other highly regulated industry
  • Expertise for failure investigations in soft- and hardware applications
  • Experience in active device and knowledge of its Standards e.g IEC 60601
  • In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
  • Good communication skills
  • Very good written and spoken knowledge in English and preferably in German

Should you be interested in a hands project in Central Switzerland, in a global Medical Device company? Kindly get in contact with me and send me your updated CV to m.becker(at)realstaffing.com or give me a call on +41 (0) 44 588 2669.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.