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Senior Software Quality Engineer - Permanent position - 100%

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Senior Software Quality Engineer
      Permanent position - 100%
                       Lausanne



Responsibilities:
  • Maintain and improve quality, reliability and safety of BINJ products: embedded software and connected web applications
  • ...
Senior Software Quality Engineer - Permanent position - 100%
Senior Software Quality Engineer
      Permanent position - 100%
                       Lausanne



Responsibilities:
  • Maintain and improve quality, reliability and safety of BINJ products: embedded software and connected web applications
  • ...

Senior Software Quality Engineer
      Permanent position - 100%
                       Lausanne



Responsibilities:
  • Maintain and improve quality, reliability and safety of BINJ products: embedded software and connected web applications
  • Actively participate in customer complaints as investigator and process leader
  • Handle Non Conformities and CAPA related to Software
  • Support Design and Process change activities. Actively collaborate with R&D and sustaining engineers.
  • Ensure Good Documentation Practices related to design and development of products.
  • Conduct Risk Management activities as process owner
  • Support Quality Management System, R&D, design transfer and development activities
  • Participate in audits program as internal auditor and suppliers' auditor
  • Improve Quality Management System processes
  • Select and evaluate offshore development suppliers (travel requirements are minimal)

Profile:
  • Master's degree in Electronics Engineering or Software Engineering
  • At least 5 years' experience in quality assurance in medical device development
  • Knowledge in cGMP and health authority expectations
  • Good communication and strong interpersonal skills
  • Analytical and pragmatic problem solving approach
  • High personal commitment
  • Able to work independently and flexible to change priorities
  • Fluent in French and English
  • Good knowledge of software development process and design control
  • Knowledge in hybrid development approach, V cycle and scaled Agile
  • Knowledge of GDPR and data privacy
  • CAPA and complaints management methodology
  • ISO 13485, MDD 93/42/EEC and MDR
  • Risk management as per ISO 14971 requirements
  • Quality auditor

Adresse

Rue du Rhône 114 1204 Genève

Site web http://www.kellyservices.ch

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