Quality Engineer I

Summary

Hitachi Particle Engineering and Services, Inc. (HPES) provides service and maintenance operations to Particle Therapy systems. 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.
• 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 increase 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, 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.
• Ability to read and interpret technical documentation.
• Capable of prioritizing multiple tasks and projects and managing time efficiently.
• Proficiency with MS Office (Word, Outlook, PowerPoint, Excel).
• Experience with ISO 9001:2015.

Pay

Expected salary for this position in the California office is $100,000, determined based on factors such as depth of experience. Employees are eligible to participate in Hitachi America’s variable pay program, subject to the program’s conditions and restrictions.