Quality Engineer - Manufacturing / Compliants

Only on W2 - No C2C

Contract Duration: 06 Months Contract

Location: Sumter, SC

CAPA Production Support Role

• On the floor support
• Check Production Lines
• Defects - Quality Problems
• Work with Production Team and Manufacturing Team to dig further for root cause analysis
• Lot of root cause analysis
• CAPA
• Excel, Minitab Possibly
• SAP good to have

Complaints RoleManage Complaints Database

• Review Complaints Details
• Root causse analysis
• Excel Exp
• Trackwise Exp - Good to have
• Minitab - Good to have

Technical Skills

Must Have

• Analytical Problem Solving
• Data Analysis
• MS Office
• Public Speaking
• Time Management

Nice To Have

• Mechanical Engineering Principles
• Methodical Problem Solving

Job Description

• ON site
• 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