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With over 90 years dedicated to medical imaging, our mission has always been the same: to improve the prognosis and quality of life of patients worldwide. From Research and Development to Support and Sales Functions, Chemical and Pharmaceutical Production and the Supply Chain, day after day over 2,800 employees undertake to provide essential innovative solutions to diagnostic and interventional imaging. Together we can achieve more and guarantee a better and more sustainable future for generations to come. Be part of the adventure. Join us!

Software Project Quality Engineer M/F

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Guerbet is hiring a Software Project Quality Engineer M/F for his Lyon (69) site.

 

As Quality representative, you will be in charge of the quality on our Software development Projects.

 

Main Responsibilities :

 

  • Ensure that the Design History File (DHF) is compliant with applicable procedures, Standards and Regulation
  • Lead the Risk Management activities according to the ISO14971 Standard
  • Define the requirements related to products’ quality and guarantee their tracking
  • Support the Project Team, notably in conducting the following activities:
    • - Verification and validation strategies
    • - Selection and supplier’s approbation
  • Verification and approbation of Software processes and systems (IS)
  • Control of procedures compliance with applicable regulations (MDR 2017, ISO62304)

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Profile :

 

  • Master’s degree, Engineer, or equivalent
  • Good experience in software development
  • 10 years’ experience or more in the pharmaceutical industry
  • Experience in project management in the medical device sector
  • Good command of quality tools (functional analysis, FMEA, risk analysis, CAPA, etc.)
  • Knowledge of regulations applicable to medical devices (ISO 13485, 21 CFR part 820)
  • Fluent in French and English, another language is an asset
  • Good interpersonal and excellent communication skills
  • Force of proposals, ability to convince
  • Solutions provider, at ease in challenges
  • Ability to lead a multidisciplinary cross-functional team
Technical Competencies :

 

  • Proficiency in Standalone Software and Embedded Software
  • Knowledge of SAAS, IAAS, PAAS solutions
  • Perfect command of Software System validation
  • Good AGILE development method use