Quality Engineer
Roles & Responsibilities
Description:
- 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.
Experience Required
- Min experience required – 2-4
- Medical Devices experience required
Skills & Certifications
- 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.
Eligibilities & qualifications
- Min education required – Bachelor’s Degree
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