Quality Engineer

Job Summary

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. The Engineer is involved in resolving equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

Qualifications

• 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
• 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

Skills

• Intermediate knowledge of quality engineering policies, principles and best practices
• Intermediate knowledge of FDA/ISO requirements
• Statistical sample size calculations
• Regulatory requirements (cGMP, FDA, ISO, etc.)
• Writing test protocols, conducting tests, collecting data, and writing reports