Software Product Assessor

hace 2 días

Madrid, Madrid, España SGS A tiempo completo
Job Description

We are seeking a highly skilled Product Assessor to join our team at SGS. As a Product Assessor, you will play a critical role in ensuring the quality and compliance of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) products.

Key Responsibilities
  • Conduct thorough technical documentation reviews of SaMD and devices using AI/Machine Learning (ML) to ensure compliance with EU regulations and standards.
  • Collaborate with cross-functional teams to increase efficiency and quality.
  • Develop and present training to others in SGS or externally as needed.
  • Project manage reviews to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.
  • Support and assist on queries raised from the review.
  • Work to adhere to KPIs set as an individual and within a team.
  • Ensure personal competency is maintained to review technical files and documentation.
  • Provide the highest level of service throughout the SGS network and to stakeholders.
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, with two years in developing SaMD and demonstrating knowledge of one or more programming languages and AI/ML models.
  • Thorough knowledge and understanding of the Software Life Cycle processes, including requirement analysis, design, coding, configuration management, testing, validation, and problem resolution techniques.
  • Knowledge and understanding of related standards, such as IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, etc.
  • Thorough knowledge and understanding of AI regulations, released standards/guidance, and AI/ML tools/libraries.
  • Good written English skills, as reports will be reviewed/queried in English.
  • Knowledge of Technical File codes desirable (COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) MDS1009 and MDS0315.
Why SGS?
  • Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
  • Enjoy a flexible schedule and remote work model.
  • Access SGS University and Campus for continuous learning options.
  • Thrive in a multinational environment, collaborating with colleagues from multiple continents.
  • Benefit from our comprehensive benefits platform.

At SGS, we value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. Apply now to be part of our motivated and dynamic team.

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