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Quality Engineer

Company: Hitachi Particle Engineering and Services, Inc.

Department: Quality

Location: Pleasanton, CA

Status: Regular, Full-Time

Summary

The Quality Engineer is responsible for ensuring products, processes, and services meet customer, engineering, regulatory, and quality requirements. This role develops and maintains inspection and test methods, quality procedures, inspection plans, and acceptance criteria; reviews drawings and specifications; supports root cause analysis and corrective actions; investigates nonconformances; and drives continuous improvement initiatives. The Quality Engineer works closely with Engineering, Manufacturing, Suppliers, and Operations to establish effective quality controls, improve processes, reduce defects, and ensure compliance with applicable quality standards and customer requirements.

RESPONSIBILITIES:

• Work with cross-functional teams to conduct and document investigations of NCRs, complaints, and CAPAs, providing effective corrective and preventive actions.
• Develop and analyze quality metrics, yield trends, and defect data to identify risks and drive measurable improvements.
• Drive quality initiatives across manufacturing, testing, and production operations to improve product and process performance.
• Manage supplier quality activities, including supplier corrective actions, performance monitoring, and issue resolution.
• Establish and maintain quality documentation, including SOPs, Work Instructions, inspection procedures, and quality records.
• Update and digitize data collection methods for manufacturing, quality, and field service. Assess opportunities to implement statistical analysis and improve quality control.
• Ability to design equipment, tools, and fixtures to improve verification processes and product quality.
• Ensure compliance with ISO 9001 and other applicable quality management standards
• Support internal, external, process, and compliance audits, including corrective action follow-up.
• Drive continuous improvement projects to improve the efficiency and effectiveness of processes.
• Perform other duties as directed by the quality manager

QUALIFICATIONS:

• BS in Electrical, Industrial Engineering or a related engineering field
• 6+ years of experience in Quality Assurance or Quality Engineering within an ISO regulated environment or equivalent education and experience
• Strong critical thinking skills, analytical abilities, and attention to detail
• Understanding of quality principles such as Lean Six Sigma, root cause analysis, statistical analysis, value stream mapping, continuous improvement, and Kanban
• Understanding of how to read and interpret technical documentation
• Capable of prioritizing multiple tasks and projects and managing time efficiently
• Proficiency with MS Office programs including Word, Outlook, PowerPoint, and Excel
• Experience with ISO 9001:2015

For California only (as required by Californias Pay Transparency for Pay Equity Act (SB 1162): The expected salary for this position in our California office is $100 K. Pay is determined based on a variety of factors including, but not limited to, depth of experience in the practice area. Employees are eligible to participate in Hitachi Americas variable pay program, subject to the programs conditions and restrictions.