Quality Manager

The purpose of the Quality Manager is to lead and manage our Quality Management System (QMS) and ensure that products, processes, and services consistently meet internal standards and customer expectations.

This role is responsible for ISO 9001 compliance, customer complaint resolution, CAPA management, internal and external audits, process improvement initiatives, and fostering a strong quality culture across operations. The Quality Manager partners cross-functionally with Operations, Engineering, Supply Chain, Service, and Sales to drive continuous improvement and operational excellence.

• Provide leadership and guidance for Quality Assurance activities supporting Operations, Sales, Service, Distributors, and Customers.
• Support the development and maintenance of the Quality Policy and Quality Management System (QMS), ensuring quality objectives are established, tracked, and achieved.
• Develop and execute an internal audit program; conduct audits and support customer and regulatory inspections.
• Ensure timely response to customer complaints and support resolution within established service standards.
• Support Quality System deployment, including implementation, documentation control, regulatory compliance, and product release sign-offs.
• Plan and implement quality policies, procedures, and continuous improvement initiatives to ensure products and services meet internal and customer standards.
• Conduct Management Review meetings to ensure ongoing performance and effectiveness of the Quality Management System.
• Design and implement quality control methods, process improvement initiatives, inspection standards, and testing procedures using Lean and/or Six Sigma methodologies.
• Define and clarify roles and responsibilities related to quality throughout the organization.
• Utilize statistical and analytical tools to identify process improvement opportunities.
• Lead and track quality improvement projects focused on cost reduction, defect reduction, and process standardization.
• Manage Corrective and Preventive Action (CAPA) processes.
• Analyze trends and lead investigations related to product complaints and internal nonconformances.
• Support customer and distributor quality-related communications and issue resolution.
• Ensure ISO 9001 certification compliance for facilities and related activities.
• Lead by example in root cause analysis and proactive problem-solving.
• Support cross-functional continuous improvement initiatives in collaboration with Operations, Engineering, Supply Chain, Finance, and other departments.
• Drive measurable improvements using Lean manufacturing principles.
• Provide training and guidance to employees on quality standards, procedures, and expectations.
• Ensure products and components—from raw materials to finished goods—meet internal and customer quality standards.
• Prepare and maintain quality documentation, including policies, procedures, manuals, work instructions, and training materials.
• Oversee the ISO 9001 program, including compliance, documentation, and audit coordination.
• Respond to facility requests related to quality standards, documentation, and regulatory clarification.
• Conduct compliance audits to assess adherence to quality standards and company policies; provide recommendations for corrective actions.
• Stay current on industry standards, regulatory updates, and quality best practices.
• Perform other duties as assigned.

• Minimum of five (5) years of progressive experience in Quality Management within a manufacturing environment.
• Bachelor’s degree in Quality, Engineering, or related technical field required;
  Master's degree preferred. Equivalent combination of education and experience may be considered.
• ISO 9001 experience required (implementation, maintenance, and audit support).
• Experience with CAPA and structured root cause analysis methodologies.
• Lean Manufacturing and/or Six Sigma certification (Green Belt or Black Belt) preferred.
• Strong understanding of manufacturing processes and quality control methods.
• Proven ability to resolve Sales/Service and Customer quality issues.
• Proficient in ISO Quality System Standards.
• Excellent analytical, decision-making, and problem-solving skills.
• Strong interpersonal, communication, and organizational skills.
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and able to navigate ERP systems and document management software.