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Astrix Inc

Quality Engineer

Astrix Inc, Los Angeles, California, United States, 90079

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Our client is a leading global specialist for high-quality plastic films, sheets and other plastic products. They are a stable, growing global organization with 30+ production sites and over 5,000 employees.

Job Title:

Quality Validation Engineer Location:

Los Angeles County, CA Salary:

$90k-110k

Direct Hire

Position Overview: The Quality Validation Engineer ensures the quality of product design and manufacturing processes. This role combines quality engineering, validation, and compliance responsibilities in a customer-facing capacity, without hands-on manufacturing or bench work.

Key Responsibilities:

Apply statistical tools for design verification and test method validation.

Lead FMEA and risk analysis meetings; document results and action items.

Investigate material failures, determine root causes, and implement corrective actions.

Support new product transfers and participate in qualification/validation of products, equipment, and processes.

Review and approve process and design document changes.

Assist R&D with test method development and validation.

Participate in internal quality audits and contribute to ISO-compliant quality systems.

Review and approve receiving inspection requirements and sampling plans; improve QC inspection methods.

Provide backfill support for QC testing, receiving inspection, and product release activities.

Support implementation of the company's overall validation strategy. Training:

1-2 months of initial training with hiring manager, then transition to independent projects. Required Qualifications:

Bachelor's degree in Engineering or related discipline.

1-3 years of validation experience (IQ/OQ/PQ, test method validation).

Experience in quality engineering: risk analysis, CAPA, root cause analysis, FMEA, lean six sigma, audits, corrective actions.

GMP and ISO 13485 quality systems experience; medical instrumentation preferred.

Familiarity with testing equipment (Instrons, pin gages, snap gages, micrometers, calipers, etc.).

Working knowledge of SPC, DOE, Six Sigma, and other fundamental quality/statistical tools.

ASQ Certified Quality Engineer (preferred).

Systems experience: MS Office (Excel, Access, PowerPoint); LIMS or PM tools a plus. Preferred Experience:

Plastics industry strongly preferred; medical device, aerospace, or food & beverage experience considered. Company Highlights:

Stable, growing global organization with 30+ production sites and over 5,000 employees.

Leading plastics manufacturer.

Ideal role for engineers or material scientists seeking customer-facing responsibilities.

INDBH