Compliance Coordinator

The Compliance Coordinator is responsible for coordinating the Corrective and Preventive Action (CAPA) program for ISO 9001-certified Quality Management Systems (QMS). This role ensures the effective management of audit findings from internal and external assessments, facilitating robust root cause analyses, corrective action planning, and ongoing monitoring through closure. 

The position plays a key role in maintaining the effectiveness and continual improvement of the QMS by driving compliance activities, performing internal audits, tracking remediation efforts, and providing management reporting on CAPA performance and quality metrics. The Compliance Coordinator may also lead or support strategic Quality Assurance initiatives, including QMS improvement projects, regulatory and standards transitions, and certification readiness activities. 

Day-To-Day Responsibilities: 

CAPA Coordination 

• Review newly issued audit findings, nonconformities, and quality concerns. 

• Coordinate root cause analysis sessions with process owners and subject matter experts. 

• Challenge and validate root cause analyses to ensure underlying systemic causes are identified. 

• Review proposed corrective action plans for adequacy and effectiveness. 

• Track CAPA progress and follow up with action owners on upcoming or overdue actions. 

• Verify completion evidence and assess whether corrective actions effectively address identified root causes. 

• Maintain CAPA records and documentation within the compliance management system. 

Audit Activities 

• Plan and schedule internal audits according to the annual audit program. 

• Prepare audit checklists and review applicable procedures, standards, and prior audit results. 

• Conduct process interviews with auditees and review objective evidence. 

• Document audit observations, opportunities for improvement, and nonconformities. 

• Present audit findings during closing meetings. 

Compliance Monitoring & Reporting 

• Monitor compliance metrics and CAPA KPIs. 

• Prepare weekly or monthly management reports on:  

• Open CAPAs 

• CAPA aging 

• Overdue actions 

• Audit findings status 

• Root cause trends 

• Recurring issues 

• Analyze compliance trends and identify areas requiring management attention. 

• Escalate significant compliance risks to management. 

Project and Special Assignments 

• Support ISO 9001 surveillance and recertification audits. 

• Participate in projects to transition the QMS to revised ISO standards. 

• Assist with implementation or enhancement of quality and compliance tools. 

• Support quality-related assessments requested by customers, partners, or regulators. 

• Contribute to quality maturity and operational excellence initiatives. 

Preferred Skills and Knowledge: 

• Strong knowledge of quality management principles and ISO 9001 requirements.  

• Demonstrated ability to facilitate root cause analysis and corrective action planning.  

• Strong analytical, organizational, and project coordination skills.  

• Excellent written and verbal communication skills.  

• Ability to work cross-functionally and influence stakeholders at all organizational levels. 

• Fluent in English 

Preferred Experience: 

• ISO 9001 Internal Auditor or Lead Auditor certification.  

• Experience in software, SaaS, technology, or regulated industries.  

• Familiarity with quality management, compliance, or GRC platforms.  

• Experience supporting quality system transitions, certification programs, or continuous improvement initiatives. 

Basic Qualifications: 

• Bachelor’s degree