Software Quality Engineer

About you:

Do you have a passion for ensuring software meets the highest standards? As a Software Quality Engineer, you'll play a crucial role in ensuring that our device software and development strategies comply with relevant industry standards, such as IEC 62304, and aligns with regulatory expectations. . You’ll be responsible for creating foundational software development processes and plans, performing risk analyses, capturing software requirements/specifications, and ensuring overall regulatory compliance. You’ll be responsible for designing and executing test strategies, both automated and manual, to identify issues early and improve our quality processes. In addition, you'll manage documentation and tracking to ensure comprehensive records of test results, defects, and resolutions, providing visibility into quality progress. We’re looking for candidates with experience in QA tools and methodologies, a strong understanding of the software development lifecycle, and exceptional analytical skills. Join our QA team and help us deliver reliable software that truly meets the needs of our users.

What you'll do:

• Create and maintain software lifecycle documentation, including software development processes/plans, configuration management plans, software maintenance/post-market plans, etc. 

• Develop and execute risk-based software testing plans, including the creation of validation test protocols and risk assessments. Ensure these plans align with the appropriate software classification requirement

• Create and maintain software requirements documents (SRS/SDS) and risk analysis documents, ensuring they accurately reflect design and functional specifications

• Establish traceability between identified risks, mitigations, verifications and validations, and requirements.

• Work closely with the V&V team to help develop and review validation plans and provide guidance on regulatory requirements/guidance on validation activities

• Work closely with Regulatory Affairs to ensure the regulatory strategy aligns with software quality goals and milestones

• Train others on following software quality system processes and mentor them on the quality focused mindset.

• Suggest and implement improvements to the software quality system to make it more effective and less burdensome.

• Support internal and external audits of the software quality system and its records. 

• Adhere to and contribute to Vital's QMS policies, SOPs, etc. to ensure in-vitro diagnostic standards and regulations for the US, CA, and EU are met.

What you’ll need:

• Experience in the software quality assurance of regulated medical devices.

• In-depth knowledge of IEC 62304 and how it guides software development and lifecycle processes

• Knowledge of and experience working in a quality system conforming to FDA 21 CFR part 820, and ISO 13485

• Experience using issue tracking tools, such as Jira.

• Familiarity reviewing code with an eye to verifiability.

• Familiarity with reviewing and reasoning about automated verifications such as unit automated tests and functional automated tests.

• Strong understanding of key QMS processes like Design Control, Document Control, Change Control, etc.

• Good communication skills and the desire to collaborate with a team of good-natured professionals in a variety of disciplines.

• An understanding of the Software Development Lifecycle (SDLC), both as described by standards and in practice.

Bonus points for:

• ASQ CSQE certification.

• Prior experience with conducting and supporting audits, internal and external.

• Familiarity with a variety of software development approaches from low formality to full formality.

• Familiarity with Rust, Python, or Nix.

• Knowledgeable about FDA regulations and requirements associated with medical device cybersecurity concerns, quality processes, and deliverables.

• Experience with compile-time safety and leveraging static analysis for software quality.

• Strong prior experience with software risk management.

• Familiarity with laboratory environments and in-vitro diagnostics.

• Appreciation of puns!

About Vital

Vital is revolutionizing the landscape of point-of-care diagnostics with our groundbreaking platform, VitalOne, designed to deliver real-time care wherever patients are. We have built a dynamic team of experts across various disciplines including chemistry, software, engineering, and microfluidics to fulfill our mission of making healthcare more accessible and proactive. At Vital, we seek tenacious, bold, and enthusiastic individuals ready to create impactful change in the healthcare industry.