Process Quality Manager

Quality engineering leader responsible for nonconformance management, CAPA oversight, validation support, supplier quality coordination, and factory quality system execution in a regulated manufacturing environment. Job Requirements Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent Experience supervising high-volume, detail-driven execution teams Experience managing daily throughput targets, queue management, and performance dashboards Working knowledge of quality system fundamentals, including NC, CAPA, and QN processes Experience operating in regulated manufacturing environments Working knowledge of SAP Strong Excel skills Experience leading analysis of defects and determining dispositions for nonconformances Experience managing CAPA investigations, root cause analysis, and corrective and preventive actions Experience supporting PFMEA assessments and associated control updates related to design changes Experience supporting manufacturing process development, design transfer, NPI, and product transfer activities Experience executing process validation protocols and supporting production builds for validation Experience analyzing data for reports, validation, and process improvement initiatives Experience supporting supplier quality investigations and related factory acceptance or transfer activities Experience managing talent, including employee selection, performance management, compensation management, and career development Preferred Skills Process Quality Management Data Analysis and Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA methodologies Regulatory requirements knowledge Manufacturing process knowledge Process monitoring Privacy, safety, and security risk assessment Technical documentation Process engineering Continuous improvement Product Lifecycle Management (PLM) People management Job Responsibilities Lead analysis of defects to determine dispositions for nonconformances and manage Non-Conformances and Quality Notifications Manage the CAPA process, including investigations, root cause determination, corrective and preventive actions, and CAPA effectiveness monitoring Ensure regular assessment of PFMEA impact and associated controls related to design changes Support manufacturing process development and design transfer activities Support Supplier Quality with investigations and supplier-related quality activities Supervise nonconformance events and investigations in the factory Oversee material review board activities for nonconformance disposition management Manage operations performance monitoring, reporting, improvement, and development within the factory Facilitate improvement programs and support analytical testing, Supplier Quality Engineering, Supplier Quality Assurance, and Purchasing Lead quality engineering and quality assurance tasks to maintain manufacturing quality systems Lead validation and process improvement activities Support completion of New Product Introduction projects and product transfers in the factory Execute process validation protocols and facilitate production builds to support validation activities Analyze data for reports, validation activities, and process improvement initiatives Drive supplier quality improvement initiatives with cross-functional teams including R D, manufacturing, and regulatory affairs Mentor and develop quality engineers to support knowledge sharing and execution of factory quality initiatives Manage team operations and talent activities to support business and quality objectives

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.