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Quality Engineer 1

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MillenniumSoft Inc

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Location:
United States , Irvine

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Quality Engineering is responsible for evaluating and ensuring product and service quality across the organization. The role works cross-functionally to support product development and maintenance by validating equipment, processes, materials, and methods while ensuring compliance with regulatory and quality standards.

Job Responsibility:

  • Support product and service quality evaluation and control activities
  • Work cross-functionally with engineering, manufacturing, and quality teams
  • Assist in resolving equipment- and process-related production issues
  • Support equipment, process, material, and method validation activities
  • Perform statistical analysis and generate quality metrics
  • Apply basic quality engineering principles, policies, and best practices
  • Support compliance with regulatory requirements (cGMP, FDA, ISO)
  • Write test protocols, execute tests, collect data, and prepare validation reports
  • Ensure products are validated and used as intended
  • Support management reviews, data preparation, and analytics
  • Perform routine quality engineering work under supervision

Requirements:

  • Entry-level to early-career experience in Quality Engineering or a related field
  • Experience supporting validation, testing, and quality documentation preferred
  • Basic understanding of Quality Engineering principles
  • Knowledge of FDA, ISO, and cGMP regulations
  • Basic statistical analysis and sample size calculations
  • Test protocol writing and execution
  • Data collection, reporting, and documentation
  • Cross-functional collaboration
  • Attention to detail and analytical thinking
  • Bachelor’s degree in Engineering, Quality, Manufacturing, or a related discipline
  • Basic knowledge of theories, practices, and procedures within quality engineering

Additional Information:

Job Posted:
January 26, 2026

Employment Type:
Fulltime
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