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Quality Engineer (Test Protocol/ Statistical Analysis)

LanceSoft Inc.
Canaan, Connecticut, United States
April 10, 2019


• 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.