Quality Engineer 1

MILLENNIUMSOFT

Irvine, CA

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

Experience Required

Entry-level to early-career experience in Quality Engineering or a related field
Experience supporting validation, testing, and quality documentation preferred

Skills & Certifications

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

Eligibilities & qualifications

Bachelor's degree in Engineering, Quality, Manufacturing, or a related discipline
Basic knowledge of theories, practices, and procedures within quality engineering

Apply

Vacancy posted 5 days ago

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