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.
Supplier Development Leader overseeing supplier quality and improvement initiatives for Sandvik's Mining division. Focused on electric assemblies and ensuring quality standards across supply base.
Quality Assurance Engineer at Expleo implementing quality management systems and improving procedures. Collaborating on audits and monitoring performance in the Toulouse office.
Ingénieur Assurance Qualité au sein de l’équipe Qualité à Toulouse. Garant du système de management de la qualité et amélioration continue dans le secteur aéronautique.
Product Quality Engineer responsible for overseeing Factory Acceptance Tests and supplier quality in battery energy storage projects. Ensuring compliance and quality standards during project phases with travel required.
Quality Engineer providing oversight on Computer System Validation at Kite Pharma. Facilitating compliance, innovation, and quality assurance in cancer treatment developments.
Quality Assurance Associate performing functional testing on online courseware for LRN, a leading ethics and compliance SaaS company, ensuring all elements work correctly and meet quality standards.
Teamlead QA responsible for leading QA activities and establishing a sustainable quality strategy at apo.com Group. Working collaboratively with development and product management in a hybrid work environment.
IT Business Analyst/QA specialist within SEB’s Calypso team, supporting trading and post - trade processing for capital markets products. Collaborating with an international Agile SCRUM team on quality assurance activities.
QA Tester focusing on test automation within a societal critical IT environment. Involves working closely with a development team across all stages from planning to execution.
Project Quality Assurance Engineer at CROWDCONSULTANTS ensuring quality compliance in space projects. Supporting QA activities across the engineering lifecycle in a regulated environment.