VIDA Diagnostics is seeking an experienced Medical Software Quality Analyst to join our team. This role will be responsible for ensuring that our medical software applications and algorithms meet the highest standards of quality, safety, and compliance. You will work closely with software developers, product managers, and regulatory teams to test and validate software applications used in healthcare settings, ensuring they meet both user needs and regulatory requirements.
Key Responsibilities:
- Software Testing:
- Design, develop, and execute test plans and test cases for medical software applications.
- Develop manual and automated testing scenarios and solutions to test AI model results and their integration into larger systems.
- Develop and execute test plans and test cases to ensure the quality of AI/ML applications.
- Analyze test results and provide feedback to the development team.
- Perform functional, regression, integration, and performance testing to ensure software reliability and functionality.
- Participate in user acceptance testing and validation of implemented solutions.
- Identify, document, and track software defects, and work with development teams to resolve issues.
- Quality Assurance:
- Ensure that software applications comply with industry standards, regulatory guidelines (such as FDA, ISO 13485), and internal quality processes.
- Ensure that delivered solutions meet requirements.
- Participate in risk assessments and ensure that software safety requirements are met.
- Conduct root cause analysis of defects and recommend corrective actions to prevent future occurrences.
- Documentation:
- Prepare and maintain detailed test documentation, including test cases, test scripts, and test reports.
- Ensure all documentation complies with regulatory requirements and is audit-ready.
- Collaborate with the regulatory team to ensure that all software validation activities are thoroughly documented and meet compliance standards.
- Collaboration:
- Work closely with cross-functional teams, including developers, product managers, and clinical experts, to understand requirements and provide feedback on software usability and functionality.
- Participate in Agile/Scrum meetings to ensure quality is embedded in the software development lifecycle from the start.
- Continuous Improvement:
- Stay up-to-date with the latest industry trends, tools, and technologies in software quality assurance and medical device software.
- Propose and implement improvements to existing testing processes to enhance the efficiency and effectiveness of quality assurance activities.
Required Qualifications:
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
- Minimum of 3-5 years of experience in software quality assurance or quality engineering, preferably within the medical device or healthcare software industry.
- Project management experience (leading a team or project, driving cross-team delivery, building processes, etc)
- Strong knowledge of software development life cycle (SDLC), quality assurance methodologies, and manual testing and building testing frameworks.
- Proficient in test automation tools and scripting languages including Python, Playwright.
- Experience with regulatory standards such as FDA, ISO 13485, and IEC 62304.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Certification in software testing (e.g., ISTQB) is a plus.
- Experience in Agile/Scrum environments.
- Experience with software medical device quality system validation practices
Preferred Skills:
- Experience with medical imaging formats such as DICOM, medical imaging viewer systems, clinical decision support systems, or other related healthcare software.
- Knowledge of HIPAA compliance and data privacy regulations.
All VIDA employees expected to be flexible and have an entrepreneurial mindset. Other duties may be assigned as needed.
VIDA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran’s status, age or disability.