Engr 1, Quality - Onsite

Job 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 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

Qualifications

• Basic knowledge of quality engineering policies, principles and best practices
• Basic knowledge of FDA/ISO requirements
• Basic statistical sample size calculations for quality determination
• Understanding of regulatory requirements (cGMP, FDA, ISO, etc.)
• Knowledge of theories, practices and procedures in a job family or skill