Quality Engineer 1, Complaints - Onsite (Urgent Need)

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
• Has basic knowledge of theories, practices and procedures in a job family or skill

Requirements

• Bachelor's degree required
• Regulatory experience
• Excel, macros, trackwise, SAP, MINITAB, root cause analysis, Fishbone Diagram
• Great communication skills
• Experience of 6 months to 2.5 years