Quality Engineer I

Hitachi, Ltd.; Pleasanton (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

Hitachi Particle Engineering and Services, Inc. in Pleasanton, CA is seeking a Quality Engineer to ensure products, processes, and services meet customer and regulatory requirements.

You will develop and maintain inspection methods, quality procedures, and acceptance criteria; review drawings and specifications; support root cause analysis and corrective actions; investigate nonconformances; and drive continuous improvement with cross-functional teams.

Qualifications

• BS in Electrical, Industrial Engineering or related field.
• 6+ years of experience in Quality Assurance/Quality Engineering in ISO environment.
• Strong critical thinking, analytical abilities, and attention to detail.
• Understanding of Lean Six Sigma, root cause analysis, statistics, value stream mapping, and Kanban.
• Ability to read and interpret technical documentation.
• Prioritize multiple tasks and manage time efficiently.
• Proficiency with MS Office (Word, Outlook, PowerPoint, Excel).
• Experience with ISO 9001:2015.

Responsibilities

• Investigate NCRs, complaints, and CAPAs; implement corrective/preventive actions.
• Analyze quality metrics, yield trends, and defect data to drive improvements.
• Lead quality initiatives across manufacturing, testing, and production operations.
• Manage supplier quality activities and supplier corrective actions.
• Maintain quality documentation: SOPs, work instructions, inspection procedures, records.
• Digitize data collection methods and apply statistical analyses for quality control.
• Design equipment/tools/fixtures to improve verification processes and quality.
• Ensure compliance with ISO 9001 and other quality standards.
• Support audits and corrective action follow-ups.
• Drive continuous improvement projects to enhance process efficiency.

Skills

Critical thinking

Analytical abilities

Attention to detail

MS Office proficiency

Quality systems knowledge

Education

BS in Electrical/Industrial Engineering

Tools

ISO 9001:2015

Job description

Job Description

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's variable pay program, subject to the program’s conditions and restrictions.

Equal Employment Opportunity (EEO)-Females/Minorities/Protected Veterans/Individuals with Disabilities

Protected veterans and qualified individuals with a disability may request a reasonable accommodation if you are unable or limited in your ability to use or access the Hitachi Energy career site as a result of your disability. You may request reasonable accommodations by completing a general inquiry form on our website. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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Use of Al and automated tools in recruitment

As part of our recruitment process, Hitachi Energy uses digital and automated tools, including Al-supported solutions, to assist with activities such as application screening, job matching, and interview scheduling. These tools are designed to support our recruiters and do not replace human decision-making. Candidate data is processed in accordance with applicable data protection and employment laws as well as Hitachis Global Data Privacy Notice.