Job DescriptionsJob Summary:
The Quality Management Representative (QMR) is responsible for ensuring the establishment, implementation, and maintenance of the organization's Quality Management System (QMS) in compliance with flowing standards, ISO 9001, ISO 14000, IATF 16949, AS9100, ISO 13485 . This role involves acting as a liaison between the organization, customers, and regulatory bodies concerning quality-related matters, driving continuous improvement initiatives, and fostering a culture of quality across the organization.
Key Responsibilities:
• Quality System Management:
- Develop, implement, and maintain the Quality Management System (QMS) in line with applicable standards and regulations.
- Monitor and evaluate the effectiveness of the QMS through audits, reviews, and performance metrics.
- Ensure compliance with quality policies, procedures, and regulatory requirements.
• Product approval felicitation:
- Support internal teams for Thai FDA approval of product and processes
- Support team for CE and US FDA validation processes
• Internal Audits:
- Plan, conduct, and oversee internal quality audits to identify areas for improvement.
- Collaborate with various departments to address non-conformities and ensure corrective and preventive actions are implemented.
• Document Control:
- Oversee the creation, revision, and distribution of QMS documentation, including policies, procedures, and work instructions.
- Maintain accurate records to support traceability and compliance.
• Customer and Stakeholder Interaction:
- Act as the primary point of contact for external audits, certifications, and customer quality-related inquiries.
- Address customer complaints and concerns by investigating root causes and implementing corrective actions.
• Training and Development:
- Organize and deliver training programs to promote quality awareness among employees.
- Guide and support team members to ensure adherence to quality standards and practices.