Quality Engineer I

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Quality Engineer

Company:Hitachi Particle Engineering and Services, Inc.

Department:Quality

Location:Pleasanton, CA

Status:Regular, Full-Time

The Company

Hitachi Particle Engineering and Services, Inc. (HPES) provides service and maintenance operations to Particle Therapy systems. Accsys Technologies, a division of HPES designs and manufactures ion RF LINAC systems (radio frequency linear accelerator), which are used in Particle Beam Therapy systems and R&D applications. Hitachi Particle Engineering and Services, Inc. is a Hitachi Group Company.

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

Our Values

We are proud to say we are an equal opportunity employer and welcome all applicants for employment without attention to any factor that doesn't impact your ability to do the job, including race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are proud of Japanese heritage, with our values expressed through the Hitachi Spirit:

Wa - Harmony, Trust, Respect

Makoto - Sincerity, Fairness, Honesty, Integrity

Kaitakusha-Seishin - Pioneering Spirit, Challenge

For California only (as required by California's 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 America's variable pay program, subject to the program's conditions and restrictions.

Equal Opportunity Employer (EOE)-Females/Minorities/Protected Veterans/Individuals with Disabilities

If you need a reasonable accommodation to apply for a job at Hitachi, please send the nature of request and contact information to accommodation@hal.hitachi.com. Queries other than accommodation requests will not be responded to.