Software Quality Engineer

Vital revolutionizes point-of-care diagnostics with VitalOne platform, delivering real-time care wherever patients are.
Backend
Mid-Level Software Engineer
Remote
Healthcare · Biotech

Description For Software Quality Engineer

Vital Biosciences Inc. is seeking a Software Quality Engineer to join their innovative healthcare technology team. This role is crucial in ensuring software quality and regulatory compliance for medical devices. The position offers an opportunity to work with cutting-edge point-of-care diagnostics technology through the VitalOne platform.

As a Software Quality Engineer, you'll be responsible for maintaining high software quality standards while ensuring compliance with industry regulations like IEC 62304, FDA 21 CFR part 820, and ISO 13485. You'll create and oversee software lifecycle documentation, develop testing strategies, and work closely with V&V teams and Regulatory Affairs.

The ideal candidate brings experience in medical device software quality assurance, strong knowledge of regulatory requirements, and expertise in quality management systems. You'll need to be proficient with issue tracking tools like Jira and have a solid understanding of software development lifecycles.

This remote position offers the chance to work with a dynamic team of experts across various disciplines, including chemistry, software, engineering, and microfluidics. You'll be part of a mission to make healthcare more accessible and proactive through innovative diagnostic solutions.

The role combines technical expertise with quality assurance, requiring someone who can balance regulatory compliance with practical software development needs. You'll have the opportunity to influence quality processes, mentor team members, and contribute to the development of life-changing medical technology.

Join Vital Biosciences Inc. to be part of a team that's revolutionizing point-of-care diagnostics and making a real impact in healthcare accessibility. This role offers the perfect blend of technical challenge and meaningful contribution to healthcare innovation.

Last updated 22 days ago

Responsibilities For Software Quality Engineer

  • Create and maintain software lifecycle documentation including development processes/plans
  • Develop and execute risk-based software testing plans
  • Create and maintain software requirements documents and risk analysis documents
  • Establish traceability between risks, mitigations, verifications and validations
  • Work with V&V team to develop and review validation plans
  • Work with Regulatory Affairs to ensure regulatory strategy alignment
  • Train others on software quality system processes
  • Support internal and external audits
  • Ensure compliance with in-vitro diagnostic standards and regulations

Requirements For Software Quality Engineer

Python
Rust
  • Experience in software quality assurance of regulated medical devices
  • In-depth knowledge of IEC 62304
  • Knowledge of FDA 21 CFR part 820 and ISO 13485
  • Experience using issue tracking tools like Jira
  • Familiarity with code review and verification
  • Strong understanding of QMS processes
  • Good communication skills
  • Understanding of Software Development Lifecycle (SDLC)

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