Product Quality Engineer II

Fujifilm•Lebanon, NH

7d•Onsite

About The Position

The Product Quality Engineer II is a fully qualified, career-level individual contributor with combined responsibility for New Product Introduction (NPI) quality and sustaining Product Quality. The role serves as the Quality representative from product development, qualification, and design transfer through production release, volume manufacturing, customer support, and continuous improvement. The engineer partners with Engineering, Program Management, Manufacturing, Operations, Supply Chain, Supplier Quality, Manufacturing Quality, and customers to ensure that product and process risks are identified and controlled, requirements are translated into effective manufacturing controls, processes are capable and ready for release, and production quality performance is sustained. The engineer leads data-driven problem solving, manufacturing quality improvement, product and process qualification, launch readiness, nonconformance management, and corrective action and may mentor junior engineers and technicians.

Requirements

Bachelor's degree in engineering, science, quality, or a related technical field and at least 5 years of related experience; or a master's degree and at least 3 years of related experience; or a PhD; or an equivalent combination of education and relevant experience.
Demonstrated experience supporting both NPI or design-transfer activities and sustaining manufacturing quality in a product-development and production environment.
Demonstrated ability to lead complex root cause and corrective-action efforts to effective, sustainable closure.
Working knowledge of manufacturing and product quality methods, including FMEA, control plans, verification and validation, Cpk/Cp, SPC, DOE, process data analysis, 8D, and DMAIC.
Ability to independently define problems, collect and analyze data, evaluate multiple contributing factors, draw valid conclusions, and implement practical changes.
Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, customers, and suppliers.
Strong written, verbal, presentation, and technical-reporting skills.
Experience directing or coordinating laboratory, test, or technical work.
Proficiency with Minitab or equivalent statistical software and Microsoft Excel, Word, PowerPoint, Outlook, and Project or equivalent project-planning tools.

Nice To Haves

Knowledge of ISO 9001 and other applicable international quality-management-system standards.
Experience supporting regulated, high-reliability, or medical-device-related products and customers.
Experience supporting NPI, design transfer, production readiness, qualification builds, and launch stabilization in a cross-functional product-development environment.
ASQ Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, or equivalent certification.
Six Sigma Green Belt or Black Belt certification.
Experience with field failure analysis, reliability testing, and Weibull or other life-data analysis.
Experience with SolidWorks, test automation, data-acquisition systems, or reliability-analysis software.

Responsibilities

Serve as the Quality lead or core team representative for NPI programs from concept and design transfer through prototype, qualification, pilot builds, production release, and post-launch stabilization.
Partner with Design Engineering, Process Engineering, Manufacturing, Supply Chain, Supplier Quality, and Program Management to define NPI quality objectives, deliverables, acceptance criteria, risks, and readiness requirements.
Lead or support NPI quality planning, including quality plans, DFMEA/PFMEA linkage, control plans, inspection strategies, measurement-system analysis, capability studies, process validation, and product qualification activities.
Participate in phase and gate reviews and provide an independent Quality assessment of product and process readiness, open risks, containment needs, and release recommendations.
Ensure critical-to-quality characteristics and customer requirements are translated into drawings, specifications, supplier controls, manufacturing controls, test methods, and acceptance criteria.
Support prototype, engineering, qualification, and pilot builds by establishing data-collection plans, reviewing build results, driving issue resolution, and confirming closure of quality-related launch actions.
Coordinate objective evidence required for design transfer and production release, including validation records, first-article results, capability evidence, control plans, work instructions, and quality records.
Monitor early production and post-launch quality indicators, lead containment and corrective action when required, and formally transition mature products to sustaining quality ownership.
Participate in the Material Review Board (MRB), evaluate and disposition nonconforming material, and coordinate supplier corrective actions with Supplier Quality Engineering.
Lead complex root cause analysis and corrective and preventive action using structured methods such as 8D, DMAIC, fault-tree analysis, 5 Whys, and cause-and-effect analysis.
Apply DFMEA, PFMEA, control plans, measurement-system analysis, capability analysis, SPC, DOE, and trend analysis to reduce manufacturing and product quality risk.
Develop, implement, and maintain inspection, test, and acceptance methods for incoming material, in-process product, production equipment, and finished product.
Analyze manufacturing, supplier, field, customer, and return data to identify adverse trends, quantify risk, and recommend changes to product requirements, control strategies, processes, or quality standards.
Drive continuous improvement in manufacturing processes, test methods, yield, reliability, defect prevention, and quality-system effectiveness.
Lead or support customer return investigations, product failure analysis, and issues that may require stop-ship or stop-production decisions. Document evidence, conclusions, risk, containment, and recommended actions.
Partner with Engineering and Field Support to identify reliability improvement opportunities through testing, failure analysis, and field and return data.
Design or specify test fixtures, control systems, and test setups.
Plan and manage multiple quality, reliability, and improvement projects, including scope, priorities, risks, deliverables, and cross-functional actions.
Represent Quality in design reviews, process reviews, product changes, customer-facing discussions, supplier interactions, and technical presentations.
Create clear technical reports and presentations that communicate data, conclusions, risk, and recommended actions to technical and nontechnical audiences.
Mentor or provide technical direction to junior engineers, technicians, and laboratory associates as assigned.
Perform other duties consistent with the role and business needs.
Ensure that quality, delivery, cost, and safety objectives within the employee’s control meet or exceed internal and external customer requirements.
Comply with the Employee Handbook and applicable site rules, procedures, training requirements, and safety expectations.
Maintain accurate, complete, and timely records in accordance with applicable document- and record-control requirements.