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Quality Engineer 1

MillenniumSoftIrvine, CAApril 15th, 2026
Roles & ResponsibilitiesSupport product and service quality evaluation and control activitiesWork cross-functionally with engineering, manufacturing, and quality teamsAssist in resolving equipment- and process-related production issuesSupport equipment, process, material, and method validation activitiesPerform statistical analysis and generate quality metricsApply basic quality engineering principles, policies, and best practicesSupport compliance with regulatory requirements (cGMP, FDA, ISO)Write test protocols, execute tests, collect data, and prepare validation reportsEnsure products are validated and used as intendedSupport management reviews, data preparation, and analyticsPerform routine quality engineering work under supervisionExperience RequiredEntry-level to early-career experience in Quality Engineering or a related fieldExperience supporting validation, testing, and quality documentation preferredSkills & CertificationsBasic understanding of Quality Engineering principlesKnowledge of FDA, ISO, and cGMP regulationsBasic statistical analysis and sample size calculationsTest protocol writing and executionData collection, reporting, and documentationCross-functional collaborationAttention to detail and analytical thinkingEligibilities & qualificationsBachelor's degree in Engineering, Quality, Manufacturing, or a related disciplineBasic knowledge of theories, practices, and procedures within quality engineering