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Quality Engineer
Quality EngineerMILLENNIUMSOFT • Tempe, AZ, United States
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Quality Engineer

Quality Engineer

MILLENNIUMSOFT • Tempe, AZ, United States
30+ days ago
Job type
  • Full-time
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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Quality Engineer • Tempe, AZ, United States

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