Job Description
Join Precision Labs, a cutting-edge biotech startup revolutionizing diagnostic solutions. We're seeking a meticulous Senior Quality Assurance Engineer to uphold our commitment to excellence in product development. In this pivotal role, you'll design and execute comprehensive test strategies ensuring compliance with FDA/ISO standards while driving continuous improvement in our quality management systems.
You'll collaborate with cross-functional teams in a fast-paced environment where your expertise directly impacts patient safety and regulatory compliance. We offer competitive benefits, flexible work arrangements, and opportunities to shape the future of medical device QA.
Responsibilities
- Develop and execute comprehensive test plans for medical devices and software systems
- Implement automated testing frameworks using Selenium, JUnit, and Python
- Lead risk-based testing methodologies and root cause analysis for defects
- Ensure adherence to FDA 21 CFR Part 820, ISO 13485, and GMP standards
- Maintain and optimize QA documentation including validation protocols and CAPAs
- Mentor junior QA engineers and conduct process improvement workshops
- Coordinate with regulatory affairs for submission documentation
Qualifications
- Bachelor's degree in Engineering, Computer Science, or related field
- 5+ years of QA experience in regulated industries (medical devices preferred)
- Expertise in test automation tools and continuous integration pipelines
- Strong knowledge of risk management (FMEA, FTA) and statistical process control
- Certified Quality Engineer (CQE) or similar professional certification
- Experience with agile methodologies and defect tracking systems (JIRA)
- Exceptional attention to detail and documentation skills