Quality Engineer

• Resolving the equipment and process-related production issues
• Activities including equipment, process, materials and method validation
• Statistical analysis and metrics to analyze those systems and processes being measured

• Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
• Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
• Has in-depth experience, knowledge and skills in own job family
• Applies knowledge and skills to complete own work
• Develops competence in own area by performing routine work
• Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
• Demonstrates intermediate knowledge of FDA/ISO requirements
• Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity

May act as mentor to less experienced team members