Quality Engineer

Job Title: Quality Engineer

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Location: Cleveland, OH

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Contract Term: 12+ Months

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• Work hours (1st Shift – 8AM – 5PM, 5 days a week)
n• Onsite worker
n• Temp position at this time
n• Interviews – Video, then in-person on-site
n• Must have (quality experience)
n• Education qualification (technical background, bachelor’s degree preferred)
n• Experience needed (3-5 years quality experience preferred)

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Description :

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Quality Engineering is responsible for product and service quality evaluation and control.

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Works cross-functionally in the development and or maintenance of products or services.

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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.

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Demonstrates basic knowledge of quality engineering policies, principles and best practices

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Demonstrates basic knowledge of FDA/ISO requirements

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Applies basic statistical sample size calculations to work for quality determination on simple projects

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Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision

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Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

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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

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Support quality system improvements and maintenance through change control, process improvements and compliance risk reduction. Support projects and daily quality tasks such as : complaints, Non-conforming materials, investigations, etc..