Manufacturing Quality Engineer

Job Title: Manufacturing (Quality) Engineer – Process Improvement, CAPA & Root Cause Department: Quality Reports To: Quality Manager FLSA Status: Exempt Job Summary In summary, this role blends quality assurance, manufacturing-process engineering, and root cause discipline to ensure products meet customer and regulatory standards while driving lasting process improvements. It is a high-leverage skill in quality management, directly impacting product reliability, compliance, and operational efficiency. This role is central to our total quality management system (TQM) and ensures compliance with regulatory and customer requirements We are seeking a highly analytical and proactive Manufacturing Engineer specializing in Process Improvement, Root Cause Analysis, and CAPA (Corrective and Preventive Actions). In this role, you will serve as the primary driver for identifying, investigating, and eliminating the underlying causes of production and product quality issues. Your mission is to establish robust, data-driven systems that permanently solve non-conformances, minimize production waste, and prevent defect recurrence. You will collaborate closely with cross-functional manufacturing, quality, and engineering teams to champion continuous improvement initiatives across our operations. . Key Roles & Responsibilities Root Cause Investigation & Failure Analysis Lead comprehensive investigations into non-conformances (NCRs), product defects, deviations, and customer complaints. Apply structured root cause methodologies (such as 5 Whys, Fishbone Diagrams/Ishikawa, FMEA, and Fault Tree Analysis) to systematically isolate the true origin of quality events. Coordinate technical failure analysis and testing on defective materials or assemblies in collaboration with production and laboratory personnel. CAPA Management & Execution Own the end-to-end CAPA program, intake/triage, investigation, root cause analysis, ensuring all corrective and preventive actions are fully detailed, realistic, and completed within established timelines. Differentiate between corrective action (fixing a problem after it occurs) and preventive action (mitigating potential issues before they happen). Design and execute effectiveness checks to verify that implemented solutions permanently eliminate the problem without introducing new process risks. Maintain and update quality system records, ensuring that CAPA documentation complies with internal protocols and regulatory standards. Monitor CAPA trends and metrics to identify recurring issues and drive continuous improvement · Compliance & Audits support internal/external audits (ISO, AS, etc.) and close nonconformances with documented root cause and CAPA. Ensure audit readiness and regulatory compliance. Process Improvement & Defect Prevention Monitor manufacturing process performance by tracking quality indicators such as yield rates, scrap, and rework metrics. Deploy Statistical Process Control (SPC) and data analytics tools (e.g., Minitab) to flag trends, anomalies, or process drift before they lead to systemic defects. Lead continuous improvement projects leveraging Lean and Six Sigma methodologies to reduce process variation, optimize workflows, and eliminate waste. Verify that implemented actions are effective and sustainable. Develop and refine proactive controls, control plans, process flow diagrams, SOPs, and work instructions to ensure consistent quality. Implement statistical process control (SPC) and measurement system analysis (MSA) to reduce variation and improve yield and lower operational risks. Support APQP/PPAP and PFMEA/DFMEA for new product launches and engineering changes. Cross-Functional Collaboration & Compliance Partner with production, quality, engineering, supply chain, and maintenance teams to troubleshoot issues, smoothly integrate corrective actions into daily molding, cnc, assembly and other processing guidelines and implement permanent fixes. Participate in internal and ext…

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