Manufacturing quality engineering

Profession (Job Category):Engineering & ScienceJob Schedule: Full timeRemote:Quality Engineer Company: Hitachi Particle Engineering and Services, Inc.Department: QualityLocation: Pleasanton, CAStatus: Regular, Full-TimeThe CompanyHitachi 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.SummaryThe 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; supports root cause analysis and corrective actions; 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 standardsSupport 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 managerQUALIFICATIONS:BS in Electrical, Industrial Engineering or a related engineering field6+ years of experience in Quality Assurance or Quality Engineering within an ISO regulated environment or equivalent education and experienceStrong critical thinking skills, analytical abilities, and attention to detailUnderstanding of quality principles such as Lean Six Sigma, root cause analysis, statistical analysis, value stream mapping, continuous improvement, and KanbanUnderstanding of how to read and interpret technical documentationCapable of prioritizing multiple tasks and projects and managing time efficientlyProficiency with MS Office programs including Word, Outlook, PowerPoint, and ExcelExperience with ISO 9001:2015Our 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, RespectMakoto - Sincerity, Fairness, Honesty, IntegrityKaitakusha-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. Equal Opportunity Employer (EOE)-Females/Minorities/Protected Veterans/Individuals with DisabilitiesIf you need a reasonable accommodation to apply for a job at Hitachi, please send the nature of request and contact information to View email address on click.appcast.io. SummaryLocation: (HPES) Pleasanton, CAType: Full time