Quality Engineer

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.