Quality Engineer

Title: Quality Engineer I

Pay Rate: $41.67/hr

Location: Irvine, CA

Note: This is a W2 contract position – 1099, C2C, & 3 rd party candidates WILL NOT be considered

Quality Engineering is responsible for product and service quality evaluation, complaints, and control. They will work cross-functionally in the development and or maintenance of products or services. The Quality Engineer is involved in resolving equipment and process-related production issues, including equipment, process, materials, and method validation, as well as statistical analysis and metrics to analyze those systems and processes being measured. They will conduct complaint investigations and complaint engineering evaluations, assisting in the investigation.

Position Qualifications:

· Ability to perform root cause failure mode assessment for electronic devices and execute engineering evaluations for complaint closure

· Demonstrated basic knowledge of FDA/ISO requirements, and ability to apply basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision

· Ability to write test protocols, tests, collect data, and write reports to validate against plans to ensure products are used as intended

· Demonstrated basic knowledge of quality engineering policies, principles, and best practices

· Ability to apply basic statistical sample size calculations to work for quality determination on simple projects

· Effective verbal and written communication skills

· A minimum of a Bachelor's Degree in an Engineering or scientific discipline (e.g., Biology, Microbiology, Chemistry)

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