Quality Engineer

Description

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 the 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.

Demonstrates basic knowledge of quality engineering policies, principles and best practices
Demonstrates basic knowledge of FDA/ISO requirements
Applies basic statistical sample size calculations to work for quality determination on simple projects
Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision

writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

Has basic knowledge of theories, practices and procedures in a job family or skill
Applies knowledge and skills to complete own work
Depends on others for instruction, guidance and direction
Develops competence in own area by performing routine work