Software QA Engineer

  • Geneva
  • Posted: Jul 16, 2021

We are currently looking for a Software QA Engineer support and maintain quality assurance processes and support multiple projects to develop new medical devices and innovative therapies. Join an independent, innovative and fast-growing company for the research and development of class III Medical Devices in neurosciences.

Responsabilities :

  • Manage all quality assurance activities related to software development, verification, validation in accordance with IEC 62304.
  • Establish software standard operating procedures, software testing methodologies, and software verification and validation protocols and reports with the software development team.
  • Oversee the validation of computer software used for requirements monitoring and measurement and used in the quality management system (AAMI TIR 36).
  • Advise and support development engineers to ensure quality and regulatory compliance for software, cybersecurity, artificial intelligence, and General Data Protection Regulation.
  • Manage risk management activities in the design and development phases (especially for cybersecurity and artificial intelligence).
  • Provide change control activities during the device lifecycle.
  • Participate in key supplier audits
  • Contribute to the implementation and improvement of the QMS according to ISO 13485 and 21 CFR 820): internal audits, CAPAs, process deployment.

Your Profile :

  • MS in Engineering or Life Sciences, with minimum 5 years of experience in Quality Assurance for medical devices (preferably with Class III medical devices).
  • Proficiency in medical device regulations including MDR 2017/745/EU, FDA 21 CFR Part 820, and ISO 13485 and ISO 14971 requirements for risk management.
  • Required experience with FDA software validation, cybersecurity and artificial intelligence guidelines, and IEC 62304 software life cycle process standard requirements.
  • Experience and/or knowledge of at least one of these areas/regulations: medical devices as Software (IEC 62304 - IEC 82304-1), networkable products (UL 2900-1), artificial intelligence of a medical device, IEC 62366-1, electrical medical device (IEC 60601) or active implantable (ISO 14708)...
  • Fluency in English ; French is an asset.

For more details, apply here or contact Morgane CAYUELA at: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Software QA Engineer

Jul 16, 2021Software QA EngineerGeneva Permanent Job mc@axepta.com Life Sciences

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