Quality Systems Engineer

The Quality Systems Engineer leads the development, maintenance, and continuous improvement of the Quality Management System (QMS) while ensuring compliance with ISO 9001 and supporting operational excellence across the organization., * Lead the development, implementation, and continuous improvement of the Quality

Management System (QMS)

• Maintain compliance with ISO 9001 requirements and support external certification audits

• Serve as the subject matter expert for quality systems, procedures, and document control

• Develop, revise, and maintain quality policies, procedures, and documentation

• Plan, coordinate, and conduct internal, supplier, and process audits

• Manage corrective and preventive action (CAPA) activities and root cause investigations

• Support nonconformance investigations and implement effective corrective actions

• Facilitate management review meetings and monitor QMS performance metrics

• Partner with Operations, Engineering, Supply Chain, and other departments to improve

product quality and process performance

• Support customer audits and customer quality requirements

• Provide training and guidance on quality system requirements and best practices

• Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies

Pay: $95,000.00 - $105,000.00 per year

• Holds a bachelor’s degree in Engineering, Quality, Manufacturing, or a related field

• Has 3-7+ years of experience in quality systems or quality engineering within a

manufacturing environment

• Demonstrates strong knowledge of ISO 9001 standards and Quality Management System

(QMS) implementation

• Has experience developing, maintaining, or improving quality management systems

• Has experience leading internal audits and supporting external certification audits

• Demonstrates strong root cause analysis and problem-solving skills

• Communicates effectively with cross-functional teams and leadership

• Is highly organized and able to manage multiple priorities independently

• Is willing to travel up to 25% as business needs require

• Has an ISO 9001 Lead Auditor certification (preferred)

• Has experience with Lean Manufacturing, Six Sigma, or continuous improvement

methodologies (preferred)

• Holds ASQ certifications such as CQE or CQA (preferred)

• Has experience with ERP systems, document control, and statistical quality tools

(preferred)

• Has experience working in regulated or process manufacturing environments (preferred)