AI Driven Quality Assurance Engineer

11 hours ago

Bengaluru, Karnataka, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Quality Assurance Engineer Role

About Anumana is a pioneering AI-driven health technology company that leverages cutting-edge artificial intelligence models for ECG-based diagnostics.

We empower healthcare providers to enhance patient care at every stage of the cardiac journey by harnessing the power of AI, our advanced algorithms combine ECG, scans, and other inputs to enable early detection and intervention for heart-related diseases.

Responsibilities
  • We collaborate with cross-functional teams to support software design and development lifecycle.
  • The verification & validation test activities for components of a Software as a Medical Device (SaMD) are executed, performed, summarised, and reported on by us.
  • Development projects meet defined development process requirements of FDA 21 CFR 820.30, EN/ISO 13485:2016, and IEC 62366-1 ensuring compliance.
  • Risk management activities for projects in compliance with ISO 14971:2019 are facilitated.
  • We support timely completion of all deliverables to drive design and development projects forward.
  • Our expertise is shared with and supports the developmental design change process for each project's specifications.
  • Non-product software tool evaluation and validation process actively participated in.
  • All design and development documents and records to support regulatory submissions ensure quality.
  • Cross-functional initiatives to drive project-based activities are led or supported.

Key Requirements

  • Bachelor's Degree or equivalent in an Engineering or scientific discipline.
  • 4+ years of experience in SaMD or SiMD medical device development, verification, and validation, or relevant quality experience.
  • Design verification and validation of medical devices experience and understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.

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