Job Description

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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