Quality Assurance Engineer II
Location
Bothell, WA
Level
Mid-Level
Department
MedTech
Type
Salary
$75,000 - $100,000
Job Description
Posted on:
2025-09-30
Responsibilities
- Qualify equipment, utilities, and facilities; validate production processes and test methods.
- Collaborate with project teams to drive risk management and focus on continuous improvement.
- Support compliance with the Cepheid Quality Management System by identifying gaps and improving processes.
- Assist during internal and external audits and support manufacturing and design control teams.
- Manage change control processes across manufacturing disciplines.
- Advise New Product Implementation teams on design control deliverables.
- Analyze test results and contribute to deviation investigations.
Job Requirements
- Bachelor’s degree in Engineering or a chemistry/life science discipline.
- 2+ years of relevant work experience in quality, validation, or engineering roles.
- Experience in qualification and validation of equipment and processes.
- Knowledge of risk analysis.
- Ability to work in laboratory environments.
- Experience in an FDA regulated industry or ISO certified organization is a plus.
- Preferred Bachelor’s degree in Chemical Engineering.
