QMS Lead

• Develop, implement and maintain the company's Quality Management System.

• Develop, implement and maintain the company's Quality Management System.
• Establish and maintain the Quality Manual, Quality Policy, procedures, SOPs, work instructions and QMS formats.
• Ensure QMS processes are implemented consistently across all applicable departments.
• Periodically review the QMS for effectiveness and suitability.
• Identify gaps in the existing system and implement improvements.
• Ensure the QMS remains aligned with business and customer requirements.

• Establish and maintain an effective document-control system.

• Establish and maintain an effective document-control system.
• Control creation, review, approval, revision and distribution of QMS documents.
• Ensure only current and approved documents are available at points of use.
• Control obsolete documents and maintain revision history.
• Maintain the master list of controlled documents.
• Ensure proper control and retention of quality records.
• Define document and record retention requirements.
• Monitor compliance with document-control procedures.

• Prepare and maintain the annual internal audit program.

• Prepare and maintain the annual internal audit program.
• Develop audit schedules based on process importance, risk and previous audit results.
• Conduct and/or coordinate internal QMS audits.
• Ensure auditors are appropriately trained and independent where required.
• Prepare audit reports and communicate audit findings.
• Monitor corrective actions arising from internal audits.
• Verify effectiveness of actions before closure.
• Maintain complete internal-audit records.

• Act as the primary QMS coordinator for certification and surveillance audits.

• Act as the primary QMS coordinator for certification and surveillance audits.
• Coordinate customer and third-party QMS audits.
• Prepare the organization for external audits.
• Ensure required QMS documents and records are readily available.
• Coordinate responses to audit findings.
• Track corrective-action commitments and closure.
• Maintain audit history and certification records.
• Ensure timely preparation for upcoming audits.

• Establish and maintain the organization's CAPA system.

• Establish and maintain the organization's CAPA system.
• Review NCRs, audit findings, customer complaints and recurring issues requiring CAPA.
• Ensure appropriate root-cause analysis is performed.
• Monitor corrective and preventive action plans.
• Track CAPA status and overdue actions.
• Verify objective evidence of implementation.
• Evaluate CAPA effectiveness before closure.
• Identify recurring issues and recommend systemic improvements.

• Maintain the QMS process for handling non-conformities.

• Maintain the QMS process for handling non-conformities.
• Ensure non-conformities are properly documented and investigated.
• Monitor corrective-action requirements.
• Maintain records of non-conformities and their disposition.
• Analyze non-conformity trends.
• Escalate significant or recurring QMS issues to management.

• Establish and maintain the QMS risk-management framework.

• Establish and maintain the QMS risk-management framework.
• Coordinate identification and assessment of process risks.
• Maintain risk registers where applicable.
• Ensure risk assessments are reviewed following significant changes or incidents.
• Monitor risk-control actions.
• Integrate risk-based thinking into QMS processes.
• Ensure high-risk processes receive appropriate management attention.

• Establish and maintain the QMS change-control process.

• Establish and maintain the QMS change-control process.
• Ensure changes to processes, documents, systems and organizational requirements are formally evaluated.
• Assess the quality and QMS impact of proposed changes.
• Ensure appropriate approvals are obtained before implementation.
• Maintain change-control records.
• Verify effectiveness after implementation where required.

• Develop QMS awareness and training programs.

• Develop QMS awareness and training programs.
• Ensure employees understand applicable QMS procedures and responsibilities.
• Coordinate training on document control, CAPA, internal auditing, risk management and other QMS requirements.
• Maintain QMS training records.
• Monitor effectiveness of QMS-related training.

• Identify opportunities to improve the effectiveness of the QMS.
• Drive QMS improvement projects.
• Analyze audit, CAPA, non-conformity and other QMS data to identify systemic issues.
• Promote preventive and risk-based approaches.
• Review the effectiveness of implemented QMS improvements.