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Fujifilm

Global precision manufacturer for healthcare

Quality Manager

Quality Engineering +1Confirmed live in the last 24 hours
Full-timeSanta Clara, CA, USA$160k - $180k

About the Job

Requirements

  • A bachelor's degree in engineering, science, quality, or a related technical discipline, or an equivalent combination of education and relevant experience.
  • At least 8 years of progressive experience in product quality, manufacturing quality, quality engineering, or quality leadership within a precision-manufacturing or high-technology environment.
  • Demonstrated experience leading technical professionals and cross-functional quality improvement initiatives.
  • Working knowledge of ISO 9001 or an equivalent quality management system standard.
  • Demonstrated experience leading quality systems, internal or external audits, corrective and preventive action, and controlled-document governance in a manufacturing environment.
  • Demonstrated experience applying statistical process control, process capability analysis, failure mode and effects analysis, control plans, root cause analysis, corrective action, and risk-based decision making.
  • Experience using manufacturing and quality data to identify trends, establish priorities, and drive measurable improvement.
  • Ability to define complex problems, collect and analyze data, draw sound conclusions, communicate risk, and implement sustainable change.
  • Strong written, verbal, presentation, and interpersonal communication skills, with the ability to influence at all organizational levels and interact effectively with customers and suppliers.
  • Proven ability to manage priorities, build accountability, develop employees, and administer policies fairly and consistently.
  • Proficiency with Microsoft Excel, Word, Outlook, and PowerPoint, plus statistical-analysis software such as Minitab or an equivalent platform.
  • Regularly sit, stand, and use hands while working with a variety of parts, tools, and equipment.
  • Standing or walking may be required for approximately 30% of the workday.
  • Each employee is responsible for ensuring that quality, delivery, and cost controls within their area meet or exceed internal and external customer requirements.
  • Each employee must follow the Employee Handbook and the rules, regulations, safety requirements, and training provided by the company.

Responsibilities

  • Develop and execute a product and manufacturing quality strategy aligned with business objectives and goals for quality, yield, cost, delivery, and capacity.
  • Participate in goal deployment, develop actionable improvement plans, measure progress, and provide clear updates during business and executive reviews.
  • Translate complex quality and manufacturing data into concise recommendations, priorities, and decisions using structured communication and risk-benefit analysis.
  • Champion a culture of quality, accountability, learning, collaboration, and prevention across the organization.
  • Provide quality leadership from product concept and development through qualification, design transfer, pilot builds, production release, launch stabilization, and sustaining production.
  • Partner with Engineering and Program Management to define quality objectives, deliverables, acceptance criteria, risk controls, qualification plans, and manufacturing-readiness requirements.
  • Lead or support product and process risk assessments, design and process failure mode and effects analyses, control plans, measurement-system analysis, capability studies, verification and validation, and product qualification.
  • Participate in phase-and-gate and design reviews, providing independent assessment of readiness, residual risk, open issues, and proposed mitigations.
  • Ensure critical product, process, material, and equipment parameters are documented, monitored, and controlled for early detection of variation.
  • Lead cross-functional yield improvement, defect reduction, escape prevention, process capability, cost reduction, and delivery or capacity improvement initiatives.
  • Coordinate Manufacturing, Engineering, Production, Equipment, and Quality teams in the planning, execution, analysis, and reporting of improvement experiments.
  • Drive effective use of statistical process control, capability analysis, failure mode and effects analysis, control plans, Define, Measure, Analyze, Improve, Control, 8D, 5 Whys, cause-and-effect analysis, Design of Experiments, and other structured problem-solving methods.
  • Partner with Manufacturing Engineering to model, measure, and improve production capacity and process performance.
  • Lead or participate in Material Review Board activities, engineering change evaluation, nonconformance disposition, and assessment of change-control effectiveness.
  • Ensure inspection, test, acceptance, and monitoring methods are effective for incoming material, in-process product, equipment, and finished product.
  • Lead or support customer quality reviews, audits, escalations, corrective actions, return investigations, and business reviews.
  • Partner with Supplier Quality and Supply Chain to address supplier-related risk, nonconformance, corrective action, and improvement opportunities.
  • Analyze manufacturing, supplier, field, customer, and return data to identify adverse trends, quantify risk, and recommend changes to products, processes, controls, or standards.
  • Collaborate with Engineering and Field Support to improve product reliability through testing, failure analysis, and disciplined use of field and return data.
  • Drive continuous improvement of the quality management system and ensure effective implementation of applicable processes and controls.
  • Provide organizational leadership and day-to-day direction for Quality Systems and Document Control personnel and priorities.
  • Ensure quality-system procedures, work instructions, forms, specifications, and records are accurate, current, accessible, and aligned with applicable business, customer, and regulatory requirements.
  • Partner with process owners to simplify and standardize quality-system processes while maintaining effective controls and audit readiness.
  • Lead or support corrective and preventive action, change control, nonconformance management, risk management, audit readiness, and effectiveness verification.
  • Develop and sustain quality information systems, dashboards, and key performance indicators that make data accessible, actionable, and reliable.
  • Maintain accurate records and reports and ensure timely escalation of significant product, process, customer, supplier, or system risks.
  • Lead, coach, and develop Quality Engineers and other quality professionals supporting multiple shifts.
  • Lead, coach, and develop Quality Systems and Document Control professionals, with clear priorities, service expectations, and development plans.
  • Establish clear goals, performance expectations, development plans, and accountability for results.
  • Create an inclusive, engaging work environment that supports employee development, retention, collaboration, and continuous learning.
  • Partner across functions to clarify ownership, resolve priorities, and build organizational capability for future growth.
  • Perform other responsibilities consistent with the purpose and level of the position, as assigned.
  • Directly supervise the internal Quality Engineering team and provide direct and indirect quality support across multiple manufacturing shifts.
  • Hire, onboard, set goals for, coach, and manage the performance and development of employees; provide recognition, succession planning, workload prioritization, and ensure effective support to business process owners.
  • Work in office, light-industrial, and cleanroom manufacturing environments; appropriate training and personal protective equipment are provided where required.
  • Occasional domestic travel and some international travel may be required.

Desired Qualifications

  • Experience in MEMS, semiconductor, microelectronics, medical device, electronics, precision manufacturing, or another high-reliability industry.
  • Experience supporting new product introduction, design transfer, qualification, manufacturing readiness, production release, and launch stabilization.
  • Knowledge of MEMS silicon wafer and die fabrication processes, cleanroom manufacturing, and electrical or mechanical assembly.
  • Experience with customer quality, supplier quality, product reliability, auditing, and field or return failure analysis.
  • Experience with Design of Experiments, measurement-system analysis, advanced statistical methods, and reliability or life-data analysis.
  • Knowledge of Geometric Dimensioning and Tolerancing practices.
  • ASQ Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Six Sigma Green Belt or Black Belt, or an equivalent certification.

About the Company

Fujifilm

Global precision manufacturer for healthcare

Fujifilm is the main operating and manufacturing arm of the Fujifilm group, turning precision chemistry, nanotechnology, and optical engineering from the film era into products for deep tech and life sciences. It runs Bio CDMO facilities that manufacture complex biopharmaceuticals and vaccines, and its materials division makes photoresists and chemical slurries essential to semiconductor and display production. In healthcare, it develops AI-powered imaging devices, endoscopes, and ultrasound systems, while also serving consumers with INSTAX instant photos and X-Series cameras. Its goal is to translate core technical capabilities into reliable, market-ready products across healthcare, electronics materials, and imaging, maintaining leadership in precision manufacturing and applied science.

Company size
501-1,000
Company stage
IPO
Headquarters
Tokyo, Japan
Founded
1934

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