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 external quality audits, providing technical expertise during evaluations of the CAPA system.
• Train and mentor operators and production staff on root cause awareness and updated quality standards.

Job Qualifications

Education & Experience

• Bachelor’s Degree in Mechanical, Manufacturing, Industrial, or Quality Engineering, or a related technical discipline.
• 3 years of experience as a Quality Engineer or Manufacturing Engineer in a high-volume fabrication, assembly, or regulated production environment.
• Demonstrated track record of leading complex root cause investigations and successfully managing a volume of CAPA cases.

Technical Skills & Certifications

· Methodology Expertise: Familiarity with QMS standards and regulatory requirements. Proficiency in root cause analysis tools and CAPA systems with the ability to interpret quality data, identify trends, and recommend corrective actions. (8D, PDCA, A3, 5 Whys, Fishbone, FMEA, and other frameworks).

· Statistical Competencies: Hands-on experience with SPC, Gage R&R, hypothesis testing, and capability analysis.

· Software Proficiency: Experience utilizing data analysis tools like Minitab, along with standard Enterprise Resource Planning (ERP) or Quality Management Systems (QMS).

· Preferred Certifications: ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt is highly preferred. Total Preventative Maintenance a plus.

Soft Skills

· Problem Solving & Critical Thinking: A natural curiosity to look past superficial explanations and dig into the underlying variables of a problem. Proactive mindset to challenge assumptions and find sustainable solutions.

· Communication: Ability to distill complex technical failures into clear, actionable summaries for corporate leadership and technical teams alike. Clear technical writing and presentation skills.

· Influence Without Authority: Strong interpersonal skills to drive accountability and process changes across different shifts and production lines. Strong project coordination and follow-through.

Pay: $52,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Work Location: In person

Salary : $52,000 - $90,000