# Quality Management System Lead

*/JobTypes/Quality_Management_System_Lead*

## Neighborhood

### Related (delivered by)

- [Plan and deploy the EQMS scope, targets, and goals](/Processes/Plan_and_deploy_the_EQMS_scope,_targets,_and_goals) — delivered by · Processes

### Perform

- [Coordinate audit responses and remediation](/Tasks/Coordinate_audit_responses_and_remediation) — perform · Tasks
- [Supervise Document Control and QMS Administration Staff](/Tasks/Supervise_Document_Control_and_QMS_Administration_Staff) — perform · Tasks
- [Own the Change Control and CAPA Processes](/Tasks/Own_the_Change_Control_and_CAPA_Processes) — perform · Tasks
- [Plan and Direct the Internal Audit Program](/Tasks/Plan_and_Direct_the_Internal_Audit_Program) — perform · Tasks
- [Approve Quality System Procedures and Policy Changes](/Tasks/Approve_Quality_System_Procedures_and_Policy_Changes) — perform · Tasks
- [Host External Certification and Customer Audits](/Tasks/Host_External_Certification_and_Customer_Audits) — perform · Tasks
- [Lead Management Review Meetings with Quality Metrics](/Tasks/Lead_Management_Review_Meetings_with_Quality_Metrics) — perform · Tasks
- [Maintain the Quality Management System Against ISO 9001 Requirements](/Tasks/Maintain_the_Quality_Management_System_Against_ISO_9001_Requirements) — perform · Tasks
- [Define quality system process architecture](/Tasks/Define_quality_system_process_architecture) — perform · Tasks
- [Drive management review of system effectiveness](/Tasks/Drive_management_review_of_system_effectiveness) — perform · Tasks
- [Lead internal audit program for the system](/Tasks/Lead_internal_audit_program_for_the_system) — perform · Tasks
- [Maintain alignment to certification standards](/Tasks/Maintain_alignment_to_certification_standards) — perform · Tasks
- [Oversee corrective action program performance](/Tasks/Oversee_corrective_action_program_performance) — perform · Tasks
- [Manage the Management Review Cycle](/Tasks/Manage_the_Management_Review_Cycle) — perform · Tasks
- [Maintain Certification Readiness](/Tasks/Maintain_Certification_Readiness) — perform · Tasks
- [Liaise with Certification Bodies](/Tasks/Liaise_with_Certification_Bodies) — perform · Tasks
- [Lead Internal QMS Audits](/Tasks/Lead_Internal_QMS_Audits) — perform · Tasks
- [Govern Document and Record Controls](/Tasks/Govern_Document_and_Record_Controls) — perform · Tasks
- [Drive QMS Process Improvements](/Tasks/Drive_QMS_Process_Improvements) — perform · Tasks

### Required knowledge

- [Internal Audit Practice](/Knowledge/Internal_Audit_Practice) — requires knowledge · Knowledge
- [ISO 9001 Standard Requirements](/Knowledge/ISO_9001_Standard_Requirements) — requires knowledge · Knowledge
- [Supplier Quality Requirements](/Knowledge/Supplier_Quality_Requirements) — requires knowledge · Knowledge
- [Risk-Based Thinking Frameworks](/Knowledge/Risk-Based_Thinking_Frameworks) — requires knowledge · Knowledge
- [Regulatory Compliance Requirements](/Knowledge/Regulatory_Compliance_Requirements) — requires knowledge · Knowledge
- [Quality Management Standards](/Knowledge/Quality_Management_Standards) — requires knowledge · Knowledge
- [Certification Criteria](/Knowledge/Certification_Criteria) — requires knowledge · Knowledge
- [Audit Methodologies](/Knowledge/Audit_Methodologies) — requires knowledge · Knowledge
- [Corrective Action Principles](/Knowledge/Corrective_Action_Principles) — requires knowledge · Knowledge
- [Process Architecture Principles](/Knowledge/Process_Architecture_Principles) — requires knowledge · Knowledge
- [Regulatory Compliance Frameworks](/Knowledge/Regulatory_Compliance_Frameworks) — requires knowledge · Knowledge
- [Certification Audit Requirements](/Knowledge/Certification_Audit_Requirements) — requires knowledge · Knowledge

### Engage in

- [Plan and Direct the Internal Audit Program](/Activities/Plan_and_Direct_the_Internal_Audit_Program) — engage in · Activities
- [Maintain the Quality Management System Against ISO 9001 Requirements](/Activities/Maintain_the_Quality_Management_System_Against_ISO_9001_Requirements) — engage in · Activities
- [Host External Certification and Customer Audits](/Activities/Host_External_Certification_and_Customer_Audits) — engage in · Activities
- [Drive management review of system effectiveness](/Activities/Drive_management_review_of_system_effectiveness) — engage in · Activities
- [Maintain alignment to certification standards](/Activities/Maintain_alignment_to_certification_standards) — engage in · Activities
- [Define quality system process architecture](/Activities/Define_quality_system_process_architecture) — engage in · Activities
- [Maintain Certification Readiness](/Activities/Maintain_Certification_Readiness) — engage in · Activities
- [Lead Internal QMS Audits](/Activities/Lead_Internal_QMS_Audits) — engage in · Activities
- [Design Quality Management System Architecture](/Activities/Design_Quality_Management_System_Architecture) — engage in · Activities

### Requires ability

- [Problem Sensitivity](/Ability/Problem_Sensitivity) — requires ability · Ability
- [Written Expression](/Ability/Written_Expression) — requires ability · Ability
- [Oral Expression](/Ability/Oral_Expression) — requires ability · Ability
- [Systems Evaluation](/Ability/Systems_Evaluation) — requires ability · Ability
- [Judgment and Decision Making](/Ability/Judgment_and_Decision_Making) — requires ability · Ability
- [Information Ordering](/Ability/Information_Ordering) — requires ability · Ability
- [Deductive Reasoning](/Ability/Deductive_Reasoning) — requires ability · Ability

### Uses software

- [MasterControl](/Software/MasterControl) — uses software · Software
- [ETQ Reliance](/Software/ETQ_Reliance) — uses software · Software
- [Microsoft PowerPoint](/Software/Microsoft_PowerPoint) — uses software · Software
- [Microsoft Excel](/Software/Microsoft_Excel) — uses software · Software
- [Power BI](/Software/Power_BI) — uses software · Software
- [Quality Management System Software](/Software/Quality_Management_System_Software) — uses software · Software
- [Document Management System](/Software/Document_Management_System) — uses software · Software
- [Electronic Quality Management System](/Software/Electronic_Quality_Management_System) — uses software · Software
- [Audit Management Software](/Software/Audit_Management_Software) — uses software · Software
- [Business Intelligence Dashboards](/Software/Business_Intelligence_Dashboards) — uses software · Software
- [Document Control System](/Software/Document_Control_System) — uses software · Software

### Type of

- [Quality Control Systems Managers](/Occupations/Quality_Control_Systems_Managers) — type of · Occupations
- [Compliance Officers](/Occupations/Compliance_Officers) — type of · Occupations

### Required skills

- [Quality Auditing](/Skills/Quality_Auditing) — requires skill · Skills
- [Process Documentation](/Skills/Process_Documentation) — requires skill · Skills
- [Metrics Analysis](/Skills/Metrics_Analysis) — requires skill · Skills
- [Cross-Functional Leadership](/Skills/Cross-Functional_Leadership) — requires skill · Skills
- [Corrective Action Management](/Skills/Corrective_Action_Management) — requires skill · Skills
- [Internal Audit Management](/Skills/Internal_Audit_Management) — requires skill · Skills
- [Standards Gap Analysis](/Skills/Standards_Gap_Analysis) — requires skill · Skills
- [Internal Auditing](/Skills/Internal_Auditing) — requires skill · Skills
- [Process Governance](/Skills/Process_Governance) — requires skill · Skills
- [Quality System Design](/Skills/Quality_System_Design) — requires skill · Skills
- [Standards Interpretation](/Skills/Standards_Interpretation) — requires skill · Skills

### Problems this exposes

- [supplier quality scorecards compiled from scattered receiving-inspection records](/Problems/supplier_quality_scorecards_compiled_from_scattered_receiving-inspection_records) — exposes problem · Problems
- [ISO 9001 document control and revision history maintained manually](/Problems/ISO_9001_document_control_and_revision_history_maintained_manually) — exposes problem · Problems
- [management-review inputs assembled by chasing each process owner](/Problems/management-review_inputs_assembled_by_chasing_each_process_owner) — exposes problem · Problems
- [CAPA effectiveness checks slip because no one owns the follow-up date](/Problems/CAPA_effectiveness_checks_slip_because_no_one_owns_the_follow-up_date) — exposes problem · Problems
- [internal audit findings duplicate prior nonconformances](/Problems/internal_audit_findings_duplicate_prior_nonconformances) — exposes problem · Problems