QA Automation Engineer

About the Opportunity

You'll be responsible for maintaining and confirming the quality of Cleerly's products and ensuring that the medical device conforms to and complies with company requirements, international standards, and federal regulations. You'll work closely with our data science and product development teams to identify risks, design and implement risk management and mitigation strategies, identify software issues and track resolutions, participate in hazard analysis and develop and improve test strategies. On any given day you could be doing one of the following:

• Developing the test plan and test cases for a new feature
• Automating the world with Cypress.io or another framework
• Contributing to our CI/CD pipeline and capabilities
• Building complex test data sets
• Manual test case execution
• Participating in hazard analysis in compliance with ISO 14971
• Exploratory testing of the application
• Building a load testing suite for our backend systems
• Testing backend APIs and services in a distributed system environment
• Performing code reviews and driving bug triage
• Participating in sprint planning and design meetings to help deliver quality at the earliest stages

TTC: $138,000 - 151,000

• Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.

Requirements

• Bachelor's degree in Computer Science, Engineering, or equivalent experience preferred
• 3-5 years of quality experience ideally with a software as a medical device
• Experience with fast-paced agile product development using JIRA
• Excellent command of the English language with ability to draft and revise QMS documents with consistency of format and language.
• A passion for quality assurance and experience building BDD test cases and scenarios
• Experience automating full test suites with Cypress.io and/or other modern test frameworks
• Prior usage of JMeter and Postman or equivalent tools
• Solid knowledge of Javascript and SQL
• Experience with vulnerability testing and cybersecurity
• Experience testing SaaS applications in the cloud, preferably using AWS
• Demonstrable ability to drive and measure quality metrics
• Passion for working in a start-up company culture
• Capability to document regulatory compliant verification test protocols and reports prior to regulatory submissions and product launch to ensure software fulfills functional requirements and meets user needs

Bonus:

• Prior work history in Digital Health
• Experience with Quality Systems pertaining to software as a medical device (SaMD)
• Knowledge of ISO13485, 21 CFR 820, IEC 62304, ISO 14971, and AAMI TIR45
• Experience conducting post-market surveillance activities, including field issue evaluation, complaint investigations, CAPAs, and NC
• Strong understanding of risk management in medical device design, software development in product development, and post-market surveillance
• Previous experience automating E2E across a distributed system