Quality Engineer (Must have Design Control)

Description

• Works cross-functionally in the development and/or maintenance of products or services.
• Resolves equipment and process-related production issues, including equipment, process, materials, and method validation, as well as statistical analysis and metrics to analyze these systems and processes.
• Demonstrates basic knowledge of quality engineering policies, principles, and best practices.
• Demonstrates basic knowledge of FDA/ISO/EUMDR requirements.
• Applies basic statistical sample size calculations to support quality determination on simple projects.
• Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, EUMDR, etc.) to support work with direct supervision.
• Writes test protocols, conducts tests, collects data, and writes reports to validate against plans to ensure products are 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.