QMS Manager

Role & responsibilities

1. QMS Management and Compliance:
• Ensure that the organizations Quality Management System meets customer, internal, ISO 9001, and regulatory/legal requirements.
• Conduct periodic management reviews and report on QMS performance.
• Manage and maintain the Quality Manual, ensuring accuracy and compliance with industry standards.
• Ensure compliance with all customer-specific quality requirements.
2. Quality Control and Inspection:
• Oversee incoming material inspection to ensure conformity to quality standards.
• Ensure the accuracy and timely calibration of monitoring and measuring devices.
• Supervise and guide inspectors and other technical staff involved in quality control.
• Ensure validation of equipment, processes, and product testing.
3. Vendor and Customer Relations:
• Evaluate and report on vendor quality systems to ensure alignment with QMS standards.
• Work closely with customers, employees, contractors, and outsourcing firms to define and develop product requirements.
4. Team Leadership and Development:
• Lead and manage a diverse team of quality engineers, auditors, analysts, inspectors, and technicians.
• Guide and support team members, fostering a collaborative and efficient work environment.
5. Documentation and Change Control:
• Ensure that the quality system documentation is properly issued, controlled, and filed.
• Manage the Change Control and Document Control systems within the department.
• Prepare procedures and instructions related to certification, audits, and regulatory inspections.
6. Performance Monitoring and Reporting:
• Monitor and review internal processes that impact product quality.
• Report to top management on QMS performance, including corrective actions and audit results.
• Participate as a key member of the Operations Management and Quality Teams.
7. Regulatory Compliance:
• Stay updated on current industry regulations, standards, and news impacting product quality.
• Ensure the organization complies with relevant quality standards and regulations.
8. Management of Quality Personnel:
• Oversee personnel within the Quality Department, including roles in Regulatory Affairs, Quality Assurance, Final Batch Release, and Documentation Control.