Quality & Operations Manager

Company DescriptionYokogawa Fluid Imaging Technologies is dedicated to advancing the study of subvisible particles in the life sciences through innovative hardware and software, including our pioneering FlowCam technology. Our solutions are used globally in over 50 countries to support research, environmental monitoring, and quality improvement in life sciences, material research, and industrial applications. With a focus on improving vaccine safety, making injectable medicines safer, and monitoring water quality, we serve a vital role in public health and environmental protection. As one of Maine’s “Best Places to Work,” we are committed to hiring talented professionals who share our mission and passion. Learn more about career opportunities at our careers page.Role DescriptionWe are seeking a full-time Quality & Operations Manager to join our team on-site in Scarborough, ME. The Quality and Operations Manager is a cross-functional leader responsible for ensuring that Yokogawa Fluid Imaging's scientific instruments are built correctly, delivered reliably, and meet all quality, compliance, and performance expectations. This role blends quality system ownership and operations, including manufacturing execution, to drive stable, scalable product flow from design through delivery.The position requires a balance of hands-on problem-solving, structured system governance, and cross-functional leadership. The manager works closely with Engineering to ensure design intent translates to robust processes, and with Customer Service to ensure issues, RMAs, and field data drive continuous improvement. Primary Duties and Responsibilities:1. Quality Management & ComplianceOwn, maintain, and improve the Quality Management System (ISO 9001 and relevant regulatory/customer requirements).Lead internal/external audits and collaborate effectively with Yokogawa's corporate quality team. Ensure documentation integrity, configuration control, and audit readiness.Define and manage acceptance criteria for incoming materials, in-process checks, calibration, and final instrument release.Lead CAPA and root-cause investigations; ensure corrective actions are verified, effective, and systemic.Oversee calibration governance, measurement traceability, and improvements to measurement systems.Develop and monitor key quality and operational performance metrics, utilize data-driven insights to drive process and product improvements that will support growth and scalability.2. Operations ManagementOversee planning and orchestration of end-to-end product flow aligned with S&OP, production execution, customer demand, and revenue targets.Ensure repeatable, efficient, and cost-controlled builds through robust processes and work instructions.Drive improvements in yield, FPY, cycle time, scrap, and rework.Execute manufacturing test, inspection, and calibration activities and partner with Engineering on test method and DFX improvements.Coordinate supply chain and materials availability.Ensure cross-functional readiness for new product releases, ECO changes, and lifecycle transitions (EOL).3. Cross-Functional CollaborationJointly with Engineering:Align on design intent, DFX, validation, calibration methods, ECO impacts, and technical investigations.Provide manufacturing and quality insights early to prevent defects and reduce risks.Define acceptance criteria for incoming materials, subassemblies, calibration, and final instrument release.Execute first-article and incoming inspections, and final instrument release.Lead Material Review Board (MRB) activities and nonconformance disposition in a manner appropriate for high-value products.Jointly with Customer Service:Lead quality governance for complaints, RMAs, warranty issues, and field failures.Ensure high-quality field data informs root cause, CAPA, and product improvement.Support delivery documentation (CoC, calibration certificates) and service procedure updates.4. Team LeadershipManage and develop a small team across quality and operations functions.Provide training and coaching on problem-solving, quality tools, and operational discipline.Model scientific thinking, rigor, and cross-functional collaboration.Supervisory Responsibilities:Manage and supervise a team of quality personnel, manufacturing technicians, and operations specialists; set goals, mentor, coach performance, and develop talent.Experience and Technical Requirements:Bachelor's degree in Mechanical, Manufacturing, or another engineering discipline.10+ years of experience in quality roles within scientific instruments, analytical equipment, or precision electromechanical systems.5+ years managing a quality and/or operations team.Demonstrated ability to execute Quality Engineering functions; experience in operations is a plus.Strong track record in QMS, CAPA, MRB audits, calibration systems, and structured problem-solving.Lean / Six Sigma / Kaizen certification or training.Intimate knowledge of ISO 9001 and instrument-relevant standards.Experience with advanced manufacturing and high-touch service environments.Proven success working cross-functionally across multiple teams.Experience supporting NPI, ECO rollouts, and lifecycle transitions.Excellent analytical abilities with proficiency in data analysis software (e.g., Excel, JMP, Tableau, Power BI).Experience with CAD, PLM, CRM, and ERP business systems.Work Environment:Office and production environment, with regular interaction across engineering, manufacturing, and service teams.Occasional travel to suppliers, logistics partners, or customer sites as needed (<10%).Physical Requirements:This position requires working in and moving around an office environment, an engineering or analytical lab, and an assembly production environment. It involves extensive use of computers and telephones in an office environment. The role includes substantial communication with employees, corporate partners, customers, visitors, vendors, contractors, and others. On occasion, work outside of regular business hours may be required. With or without reasonable accommodations, the position will be able to:Work in an office environmentUse telecommunication toolsWork in an assembly production environmentLift an instrument (up to 50 lbs)