Quality Engineer

About the Role:
The Quality Engineer, also known as QA Engineer or Manufacturing Quality Engineer, is responsible for supporting and improving quality systems, processes, and product performance within a manufacturing environment. This role focuses on ISO 9001 compliance, process validation, root cause analysis, and continuous improvement initiatives. The Quality Engineer works cross-functionally with engineering, production, and quality teams to ensure products meet specifications, regulatory standards, and customer expectations while driving operational excellence.

Responsibilities:

• Support and maintain the Quality Management System in compliance with ISO 9001 standards and internal quality procedures
• Perform root cause analysis and lead corrective and preventive actions using methodologies such as CAPA, 8D, and Fishbone analysis
• Develop and implement quality plans, inspection procedures, and test methods for manufactured products
• Conduct internal audits, support external audits, and ensure audit readiness across manufacturing operations
• Analyze quality data using statistical tools such as SPC, SQC, FMEA, and DOE to identify trends and drive improvements
• Collaborate with manufacturing and engineering teams on process validation, process capability studies, and continuous improvement initiatives
• Investigate nonconformances, customer complaints, and supplier quality issues, ensuring timely resolution
• Support design and development activities including design reviews, risk assessments, validation, and verification processes
• Create and maintain documentation including SOPs, work instructions, and quality records
• Prepare reports and present quality metrics, KPIs, and improvement initiatives to leadership

Qualifications:

• Bachelor's degree in Engineering, Quality, or a related technical field
• 2 to 5 years of experience in quality engineering, manufacturing quality, or process quality roles
• Strong knowledge of ISO 9001 standards and quality management systems
• Experience with quality tools and methodologies including SPC, SQC, FMEA, DOE, and root cause analysis
• Familiarity with ERP or MRP systems in a manufacturing environment
• Proficiency in data analysis tools, Microsoft Excel, and reporting software
• Strong analytical, problem-solving, and organizational skills
• Excellent communication skills with the ability to collaborate across cross-functional teams
• High attention to detail and ability to manage multiple priorities in a fast-paced environment

Desired Qualifications:

• Experience in advanced manufacturing, electronics, materials science, or precision components
• Certification such as ASQ Certified Quality Engineer (CQE) or Six Sigma Green Belt
• Experience with process validation, risk management, and reliability engineering
• Knowledge of Lean Manufacturing and continuous improvement methodologies
• Experience supporting supplier quality management and audits
• Familiarity with regulatory standards in highly controlled or technical industries