Engr , Quality

Overview

Position: Quality Engineer I

Job Type: W2 Contract

Location: Irvine, CA (Fully Onsite 5 days per week Mon-Fri Required)

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
• Supports management review and data preparation entry and analytics for the site
• 1-2 years’ experience reading drawings and using measuring tools like caliper, ruler and vision system
• Conversant with GLP/GCP/cGMP and global Drug and Device Development Processes
• Excellent communication and interpersonal skills
• Organized and self-motivated

• 1-2 years’ experience reading drawings and using measuring tools like caliper, ruler and vision system
• Conversant with GLP/GCP/cGMP and global Drug and Device Development Processes
• Excellent communication and interpersonal skills
• Organized and self-motivated