Job Description
Join Precision Labs Inc. as we revolutionize medical device testing with cutting-edge QA automation. We seek a meticulous Senior QA Engineer to architect robust test frameworks ensuring compliance with FDA regulations and ISO 13485 standards. You'll lead quality initiatives for our next-generation diagnostic platforms, directly impacting patient safety and regulatory compliance.
Our Austin hub features state-of-the-art testing labs, hybrid work flexibility, and continuous learning opportunities. Collaborate with cross-functional teams in a fast-paced environment where your expertise drives product excellence.
Responsibilities
- Design and implement automated test frameworks using Selenium/Cypress for web-based medical devices
- Execute manual and automated test suites covering functional, regression, and performance testing
- Document test cases, defects, and QA processes in JIRA/ALM
- Lead root cause analysis for critical defects and implement preventive measures
- Validate compliance with 21 CFR Part 820 and ISO 13485 quality standards
- Mentor junior QA engineers on best practices and automation techniques
- Collaborate with DevOps to integrate QA pipelines into CI/CD workflows
Qualifications
- Bachelor's degree in Engineering, Computer Science, or related field
- 5+ years of QA experience in regulated industries (medical devices/pharma preferred)
- Expertise in test automation frameworks (Selenium, Cypress, or Playwright)
- Strong knowledge of Agile/Scrum methodologies and defect tracking tools
- Familiarity with risk-based testing approaches and validation protocols
- Certification in ISTQB or ASQ CQA highly desirable
- Experience with API testing (Postman, RestAssured) and performance testing tools
- Excellent analytical skills and attention to detail