Job Description
Join Precision Labs Inc., a cutting-edge biotechnology pioneer, as we revolutionize healthcare diagnostics. Our Austin-based R&D hub seeks a meticulous Senior QA Engineer to safeguard product integrity through rigorous testing protocols. You'll collaborate with cross-functional teams to implement world-class quality systems in a fast-paced, innovation-driven environment. Enjoy competitive benefits, flexible work arrangements, and the opportunity to impact millions of lives.
Responsibilities
- Design and execute comprehensive test plans for medical device software and hardware
- Lead root cause analysis for product defects and drive corrective actions
- Maintain ISO 13485 and FDA compliance documentation
- Implement automated testing frameworks using Selenium and Python
- Coordinate with suppliers to validate component quality standards
- Mentor junior QA engineers and establish best practices
- Analyze metrics to identify quality improvement opportunities
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related field
- 5+ years in QA/QC for regulated industries (medical devices preferred)
- Expertise in risk-based testing methodologies (FMEA, FTA)
- Strong proficiency in defect tracking tools (JIRA, Bugzilla)
- Experience with CI/CD pipelines and automated testing
- Certified Quality Engineer (CQE) or equivalent certification
- Demonstrated knowledge of 21 CFR Part 820 compliance
- Excellent analytical and communication skills