Job Description
Join Precision Labs, a pioneering biotech innovator, as our Senior Quality Assurance Engineer. You'll be the guardian of excellence in our cutting-edge research and development pipeline. In this pivotal role, you'll design and execute robust QA frameworks that ensure regulatory compliance (ISO 13485, FDA) and product integrity. Collaborate with cross-functional teams to embed quality-first principles from concept to commercialization. We offer competitive benefits, professional development stipends, and a culture where your expertise directly impacts life-changing innovations.
Responsibilities
- Develop and implement comprehensive test plans for medical devices and diagnostic systems
- Lead root cause analysis for quality deviations and drive corrective actions
- Automate test suites using Selenium/Cypress and maintain CI/CD pipelines
- Ensure compliance with 21 CFR Part 820 and ISO 13485 standards
- Mentor junior QA engineers and champion continuous improvement initiatives
- Generate and maintain quality documentation (DHRs, CAPAs, SOPs)
- Collaborate with R&D to design quality into product development lifecycle
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related field
- 5+ years in QA for regulated industries (medical devices preferred)
- Expertise in risk-based testing and validation methodologies
- Proficiency with automation tools (Selenium, Appium) and defect tracking systems
- Strong understanding of FDA QSR and ISO 13485 requirements
- Certified Quality Engineer (CQE) or Six Sigma Green Belt preferred
- Experience with Agile/Scrum development environments
- Exceptional analytical problem-solving and documentation skills