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
• Supports quality system improvements and maintenance through change control, process improvements and compliance risk reduction.
• Supports projects and daily quality tasks such as : complaints, Non-conforming materials, investigations, etc..