Senior Quality Assurance Specialist

6 days ago

Bengaluru, Karnataka, India beBeeQualityEngineer Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

About Anumana:

Anumana is a new AI-driven health technology company developing cutting-edge artificial intelligence models for ECG-based diagnostics. Our advanced algorithms leverage ECG, scans, and other inputs to enable early detection and intervention for heart-related diseases. By harnessing the power of AI, we empower healthcare providers to enhance patient care at every stage of the cardiac journey.

Responsibilities:

  • Participate in cross-functional teams supporting software design and development lifecycle.
  • Author, execute, perform, summarise, report out verification & validation test activities of components of a Software as a Medical Device (SaMD); which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Traceability Matrices, and Final Reports.
  • Ensure development projects meet defined development process requirements of FDA 21 CFR 820.30, EN/ISO 13485:2016 and IEC 62366-1.
  • Ensure software development is compliant with IEC 63204:2015 standard.
  • Facilitate the development of risk management activities for projects in compliance with ISO 14971:2019.
  • Ensure timely completion of all deliverables to support the design and development projects.
  • Share expertise with and support the developmental design change process for each project's specifications.
  • Actively participate in non-product software tool evaluation and validation process.
  • Ensure the quality of all design and development documents and records, so that they readily support regulatory submissions.
  • Support project-based activities through leading or supporting cross-functional initiatives.
  • Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.

Education and Qualification:

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

Skills and Qualifications:

  • Excellent communication (oral and written) and interpersonal skills within all levels of the organization
  • Ability to manage projects efficiently and effectively.
  • Collaborative mindset with openness to working towards shared goals.
  • Proactive and self-driven individual possessing due sense of urgency
  • Strong analytical and problem-solving abilities.

What We Offer:

  • The opportunity to work with innovative technologies and collaborate with brilliant minds.
  • A comprehensive benefits package including stock options, paid time off, healthcare insurance, gym/broadband reimbursement.

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