Job Title: Quality Engineer – ISO 9001
Job Type: Full-Time (Permanent)
Location: Chelmsford, MA (100% Onsite)
Only (USC/GC) on W2/FULL TIME
Job Summary
We are seeking a detail-oriented and proactive Quality Engineer to join our team in Chelmsford, MA. This role will support quality assurance and continuous improvement initiatives within a manufacturing environment, ensuring compliance with ISO 9001 standards and maintaining high product quality throughout production processes. The ideal candidate will have hands-on experience with production floor quality activities, quality systems, audits, and root cause investigations, preferably within electromechanical or cable assembly manufacturing environments.
Key Responsibilities
• Support and maintain the company’s Quality Management System (QMS) in alignment with ISO 9001 and/or ISO 13485 standards.
• Monitor and improve product quality across manufacturing and production operations.
• Conduct internal quality audits and assist with quality system registrations and compliance activities.
• Lead and support Corrective and Preventive Actions (CAPA) processes to resolve quality issues effectively.
• Perform root cause analysis using methodologies such as 8D, 5 Whys, Fishbone Diagram, and other quality tools.
• Collaborate with manufacturing, engineering, and operations teams to implement corrective actions and drive continuous improvement.
• Support and oversee inspection processes, including First Article Inspection (FAI), in-process inspections, and final inspections.
• Analyze quality data and generate reports to identify trends and opportunities for process improvement.
• Ensure quality documentation is complete, accurate, and compliant with internal and external standards.
• Provide support during customer audits and external quality assessments.
Required Qualifications
• Minimum 2+ years of Quality Engineering or Quality Assurance experience in a manufacturing environment.
• Experience working with electromechanical assemblies, cable assemblies, or wire harnesses.
• Working knowledge of ISO 9001 and/or ISO 13485 standards and quality systems.
• Experience supporting Quality Systems registration activities.
• Hands-on experience with production floor quality operations.
• Strong understanding of CAPA, Root Cause Analysis, and quality problem-solving methodologies (8D, 5 Whys, Fishbone).
• Experience conducting internal audits and supporting quality management systems.
• Knowledge of inspection processes, including FAI, in-process inspection, and final inspection.
• Strong analytical, organizational, documentation, and communication skills.