Product Quality Engineer working at OrganOx to enhance organ transplantation technologies. Responsible for quality testing, analysis, and continuous improvement in a collaborative environment.
About the role
- QA Engineer developing E2E automation framework for web and mobile applications in healthcare. Ensuring quality and regulatory compliance in a hybrid work environment.
Responsibilities
- Architect, build, and maintain a robust, scalable, and maintainable E2E automation framework (e.g., using Playwright) from scratch.
- Design and implement effective test data creation, cleaning, and management strategies.
- Define, monitor, and report on key quality metrics to drive product and process improvements.
- Develop and execute automated verification test cases and procedures to verify system requirements for our Software as a Medical Device (SaMD) products.
- Break down feature components and design specifications into structured test plans, considering functionality, user experience, and regulatory risks.
- Develop and manage verification testing, which may be manual, semi-automated, or fully automated.
- Integrate automation tests into CI/CD pipelines to provide rapid feedback to the engineering team.
- Act as the subject matter expert for testing processes, ensuring regulatory compliance (FDA QSR, ISO 13485) through rigorous software testing, issue tracking, and documentation.
- Collaborate closely with design, engineering, and product teams to identify gaps, mitigate risks, and ensure quality is built into the development lifecycle.
- Work with customer success and engineering teams to investigate, reproduce, and verify bug fixes.
- Write and improve process documents related to the software testing lifecycle.
Requirements
- Bachelor's degree in Computer Science, Biomedical Engineering, or equivalent work experience.
- 5+ years in Quality Assurance or a related technical role.
- Proven experience building an E2E automation framework from the ground up.
- Strong proficiency with a scripting language (e.g., Python, JavaScript/TypeScript) for writing automated tests.
- Direct experience with modern UI automation tools (e.g., Playwright, Cypress, Selenium).
- Experience with test strategy design patterns (e.g., Page Object Modeling - POM).
- Familiarity with CI/CD practices and tools (e.g., BitBucket Pipelines, Jenkins, GitLab CI).
- Experience with Atlassian products (Jira, Confluence) and version control (Git).
- Knowledge of relational databases.
- Excellent communication skills in a remote/hybrid environment.
- Personal qualities of integrity, perseverance, and commitment to the mission.
- Experience in healthcare technology, medical devices, or another highly regulated industry (preferred).
- Expertise or direct experience with regulatory standards (e.g., FDA QSR, ISO 13485:2016, EU MDR) (preferred).
Benefits
- Remote and flexible schedule - we are a remote company with hybrid options and support for flexible schedules!
- Health, dental, and vision insurance with options to choose a plan that fits you and your dependents needs.
- Paid time off options - we want our employees to rest, recharge, and feel better.
- Stock options - we want team members to feel ownership in the organization. When EnsoData does well, you do well.
- Company Bonus Program - if we do well, we want to reward our team members! This position may include participation in the company bonus program.
- 401k to help people invest in the future.
- Team Summits! We look forward to opportunities to gather in person and enjoy a few days together. We participate in team events and gain some great in-person time.
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