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.
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: firstname.lastname@example.org
Life Sciences Recruitment Specialist
Team Leader & Recruitment Management Life Sciences