More jobs:
Quality Engineer
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-01-25
Listing for:
MillenniumSoft, Inc
Full Time
position Listed on 2026-01-25
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Roles & Responsibilities
- 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
- 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
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