Global Quality Systems Manager

Global Quality Systems Manager

Position Summary

The Global Quality Systems Manager is responsible for leading and continuously improving Qualitrol's global Quality Management System (QMS) to ensure compliance with customer, regulatory, and international quality standards. This role serves as the global process owner for quality systems, document control, audit management, corrective and preventive action effectiveness, quality data governance, and enterprise quality applications.

The Global Quality Systems Manager collaborates with Quality, Operations, Engineering, Supply Chain, Service, and Commercial teams to standardize quality processes across all Qualitrol locations while supporting site-specific business needs. This position drives a proactive culture of compliance, continuous improvement, digital transformation, and operational excellence.

Essential Duties and Responsibilities

Global Quality Management System Leadership

• Own and maintain the global Quality Management System (QMS) architecture, policies, procedures, standards, and governance framework.

• Ensure consistent implementation and adherence to global quality processes across all sites.

• Lead global process standardization initiatives while supporting appropriate local requirements.

• Manage periodic QMS reviews and drive continuous improvement of quality system effectiveness.

• Serve as the global process owner for key quality system workflows and performance metrics.

Regulatory and Certification Compliance

• Lead maintenance of ISO 9001 certification and support implementation of additional standards as required.

• Coordinate external certification, surveillance, customer, and regulatory audits.

• Ensure audit readiness across all global locations.

• Monitor emerging regulatory requirements and assess impacts to Qualitrol operations.

• Support compliance initiatives related to customer-specific requirements and industry regulations.

Internal Audit Program Management

• Develop and maintain the global internal audit program.

• Train and mentor internal auditors across locations.

• Ensure audit findings are effectively addressed through timely corrective actions.

• Monitor closure and effectiveness of audit-related corrective actions.

• Report audit performance and risks to leadership.

Document Control and Quality Governance

• Manage the global document control process and documentation hierarchy.

• Ensure controlled documents remain current, compliant, and accessible.

• Maintain governance of quality records, retention requirements, and revision control.

• Support deployment and standardization of best practices across functions and sites.

Enterprise Quality Systems Management

• Serve as business owner for the enterprise Quality Management System (eQMS).

• Drive system implementation, enhancements, configuration management, validation, and user adoption.

• Maintain data integrity across quality applications and reporting platforms.

• Partner with IT and business stakeholders on digital quality initiatives.

• Lead training programs related to quality systems, workflows, and reporting tools.

CAPA and Nonconformance System Effectiveness

• Govern enterprise Corrective and Preventive Action (CAPA) processes.

• Monitor nonconformance, deviation, and corrective action system performance.

• Facilitate root cause analysis and corrective action effectiveness reviews.

• Drive closure of systemic quality issues through structured problem-solving methodologies.

Quality Data and KPI Management

• Establish and maintain global quality reporting standards.

• Ensure accuracy and consistency of quality performance metrics.

• Analyze enterprise quality trends and identify opportunities for improvement.

• Develop executive dashboards and management review reporting.

• Support data-driven decision making through meaningful quality analytics.

Leadership and Continuous Improvement

• Lead, coach, and develop Quality Systems professionals and quality analysts.

• Promote Lean, Six Sigma, and continual improvement methodologies throughout the organization.

• Facilitate cross-functional quality improvement initiatives.

• Support strategic quality objectives and annual operating plans.

• Drive a proactive quality culture focused on prevention and systems thinking.

Qualifications

Education

• Bachelor's degree in Engineering, Quality, Manufacturing, Operations, Business, or related technical field required.

• Master's degree preferred.

Experience

• Minimum 8-10 years of progressive quality leadership experience in a manufacturing environment.

• Minimum 5 years of Quality Management System ownership or quality systems leadership experience.

• Proven experience managing multi-site quality systems and compliance programs.

• Experience leading ISO certification and surveillance audits.

• Experience implementing or administering enterprise QMS software solutions.

Technical Knowledge

• Expert knowledge of ISO 9001 Quality Management Systems.

• Strong knowledge of corrective action systems, CAPA, root cause analysis, and audit methodologies.

• Experience with document control systems and quality governance processes.

• Knowledge of PFMEA, DFMEA, Control Plans, SPC, APQP, PPAP, and structured problem-solving methodologies.

• Experience with enterprise quality platforms such as ComplianceQuest, Oracle Fusion QMS, ETQ, or equivalent systems.

Preferred Certifications

• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)

• ASQ Certified Quality Auditor (CQA)

• ISO 9001 Lead Auditor

• Lean Six Sigma Green Belt or Black Belt

Key Performance Indicators

The Global Quality Systems Manager is accountable for:

• Successful maintenance of global ISO certifications.

• Internal and external audit performance.

• CAPA closure effectiveness and timeliness.

• Quality system compliance and process adherence.

• eQMS adoption and system utilization.

• Document control cycle time and effectiveness.

• Quality data integrity and reporting accuracy.

• Global quality training compliance.

• Reduction of recurring systemic quality issues.

Core Competencies

• Strategic Quality Leadership

• Quality Management Systems Expertise

• Regulatory Compliance Management

• Audit Leadership

• Change Management

• Data Analytics and Reporting

• Continuous Improvement

• Cross-Functional Collaboration

• Process Governance

• Coaching and Talent Development

Location: Fairport, NY (Global Responsibility)
Reports To: Director of Global Quality
Travel: Up to 25% domestic and international

#LI-PW1