Overview We are seeking a dynamic and detail-oriented Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. In this pivotal role, you will champion the development, implementation, and continuous improvement of quality systems that ensure our products meet the highest standards of safety, compliance, and excellence. Your leadership will drive a culture of quality, foster cross-functional collaboration, and uphold regulatory and legal standards essential to our industry. Join us if you are passionate about elevating product integrity through innovative quality management practices and thrive in a fast-paced industrial environment. Responsibilities Develop, monitor, and report key manufacturing and quality performance metrics (KPIs), including yield, throughput, scrap, rework, on-time delivery, and cost of quality. Identify production, process, and quality issues; lead root cause investigations utilizing structured problem-solving methodologies such as 8D, DMAIC, Fishbone Analysis, and 5-Why Analysis. Own the Engineering Change Order (ECO), Deviation, and Change Control processes, ensuring timely implementation, risk assessment, effectiveness verification, and closure. Maintain ownership of the

ISO 9001

Quality Management System (QMS) and ensure continued compliance with customer, regulatory, and internal requirements. Develop, revise, and maintain quality procedures, work instructions, process documentation, validation protocols, and records required for QMS compliance. Lead Material Review Board (MRB) activities, including disposition of nonconforming material, corrective actions, containment plans, and implementation of preventive measures. Oversee incoming inspection activities and supplier quality processes to ensure purchased materials and components meet engineering and quality specifications. Monitor and analyze process performance utilizing Statistical Process Control (SPC), capability studies, trend analysis, and data-driven continuous improvement initiatives. Manage supplier quality performance, coordinate corrective actions, and drive resolution of supplier-related quality, delivery, and process issues. Develop and execute process validation, equipment qualification, and quality assurance plans for new and existing manufacturing processes. Support new product introduction (NPI) activities by establishing manufacturing controls, process validations, inspection methods, and quality acceptance criteria. Lead internal and external quality audits, customer audits, and certification audits; ensure timely closure of audit findings and corrective actions. Drive continuous improvement initiatives focused on increasing yield, reducing defects, improving cycle times, and enhancing manufacturing efficiency. Partner with Engineering, Operations, Supply Chain, and Quality teams to improve product reliability, manufacturability, and overall operational performance. Ensure compliance with environmental, health, safety, and radiation-related requirements applicable to X-ray tube manufacturing operations. Oversee production planning and resource allocation to meet customer demand, delivery commitments, and business objectives. Lead, mentor, and develop manufacturing, quality, and technical personnel while fostering a culture of accountability, quality, and continuous improvement. Requirements Proven experience practicing in a manufacturing environment with a strong focus on quality assurance and control. Extensive knowledge of industry-specific standards including ISO 9001 and GMP (Good Manufacturing Practice). Experience with quality audits and working within an established quality system in manufacturing environments. Strong analytical skills with the ability to interpret data for process improvements; familiarity with Six Sigma manufacturing methodologies is highly desirable. Proficiency in quality inspection techniques, GD&T principles, and regulatory compliance standards relevant to manufacturing sectors. Leadership experience managing teams in a fast-paced setting with excellent cross-functional communication skills. Ability to analyze complex problems quickly and develop effective solutions aligned with regulatory requirements. Bachelor's degree in Engineering, Quality Management, Quality Assurance or related field. Join us as a Quality Manager if you are eager to influence product excellence through strategic leadership in quality systems—empowering teams to deliver safe, compliant, and superior products that meet global industry standards!

Pay:

$84,813.01 - $102,140.40 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): +3 years manufacturing experience

Education:

Bachelor's (Required)

Experience:

Quality management: 3 years (Required) Ability to

Commute:

Santa Cruz, CA 95060 (Required)

Work Location:

In person