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Quality Engineering is responsible for managing a new product transfer from design into manufacturing at the Tempe location. 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 intermediate knowledge of quality engineering policies, principles and best practices.
Job Responsibility:
Quality Engineering is responsible for managing a new product transfer from design into manufacturing at the Tempe location.
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 intermediate knowledge of quality engineering policies, principles and best practices.
Requirements:
Min experience required – 2-4
Medical Devices experience required
Demonstrates intermediate knowledge of FDA/ISO requirements.
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity.
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision.
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.