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Software QA Engineer
View: 116
Update day: 26-03-2024
Category: IT - Hardware / Networking Information Technology Arts / Design
Industry:
Job type: Durée indeterminée
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Job content
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
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Deadline: 10-05-2024
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