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
