Software and Artificial Intelligence Product Assessor

hace 4 semanas


Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completo

Software and Artificial Intelligence Product Assessor - Active Devices

We are SGS, the world's leading testing, inspection and certification company. Our mission is to enable a better, safer and more interconnected world.

Job Description

As a Product Assessor for Software and AI, you will play a key role in ensuring the quality and safety of medical devices. Your responsibilities will include:

• Conducting thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) and ensuring compliance with EU regulations and standards.

• Collaborating with cross-functional teams to increase efficiency and quality.

• Developing training and presenting the training to others in SGS or externally as deemed necessary.

• Project managing reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

• Supporting/assisting on queries raised from the review.

• Working at all times to adhere to KPI's set as an individual and within a team.

• Ensuring personal competency is maintained to be able to review technical files and technical documentation.

• Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.

Qualifications

Bachelor's degree in a related discipline (e.g., engineering, or other relevant sciences).

Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in developing SaMD demonstrating knowledge of one or more programming languages (preferable in MDSW or other critical software requiring compliance with regulations) and AI/ML models in specific industry/academic research.

Thorough knowledge and understanding of the Software Life Cycle processes: requirement analysis, design and coding, configuration management including version and change control, testing including unit, integration, regression and system testing, validation and release, and problem resolution techniques including debugging techniques, root cause analysis and code reviews.

Knowledge and understanding of the related standards: IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, etc.


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