ตำแหน่ง QMR&QA Manager

บริษัท Orthopeasia Co., Ltd.

ที่อยู่บริษัท

เงินเดือน สำหรับสมาชิกเท่านั้น

ลักษณะงานที่ทำ
maintain comprehensive quality management systems to ensure compliance with
industry standards and regulations, including ISO 13485, GMP, Thai FDA, and US
FDA
•
Lead and manage quality assurance team: Supervise and mentor QA staff, providing
guidance and support to ensure effective performance and adherence to quality
standards.
•
Conduct internal and external audits: Plan and execute internal audits and support
external audits to verify compliance with regulatory requirements and company
standards.
•
Oversee CAPA (Corrective and Preventive Action) and complaint processes: Develop,
implement, and manage CAPA and complaint plans to address non-conformities and
prevent recurrence.
•
Monitor and report on quality metrics: Utilize statistical analysis tools to track and
analyze quality performance indicators and provide regular reports to senior
management.
•
• Prepare the document relevant such as CSDT, TDF files and GSPR
Support regulatory submissions and inspections: Prepare and review
documentation for regulatory submissions and assist in inspections by Thai FDA
and US FDA.
•
Collaborate with cross-functional teams: Work with various departments to drive
continuous improvement in product quality and ensure regulatory compliance.
•
Manage document control: Oversee the creation, review, and control of qualityrelated
documents to ensure accuracy and compliance.
•
Develop and deliver training programs: Create and implement training for staff on
quality standards, processes, and procedures to enhance overall quality awareness
and capability.
•
• Performed risk assessments and maintained risk management documentation.
• Control document for the quality management system.
• Submit the management review report to the Managing Director.
Monitor Key Performance Indicators (KPIs) and report findings to the Managing
Director.

ตำแหน่ง QMR

บริษัท Chemical Innovation Co., Ltd

ที่อยู่บริษัท

เงินเดือน สำหรับสมาชิกเท่านั้น

ลักษณะงานที่ทำ
Managed quality management system documentation for ISO 9001, ISO/IEC 17025
and ISO 17034 certification.
•
Conducted internal and external audits to ensure compliance with regulatory
requirements.
•
Implemented corrective actions to address non-conformities and improve
processes.
•
Collaborated with cross-functional teams to drive continuous improvement
initiatives.
•
• Led training sessions on quality management principles and practices.
• Handled preventive maintenance and calibration of laboratory equipment.
Checked and verified calibration data sheets for technical accuracy based on
specification and approved procedures

ตำแหน่ง ISO Internal Auditor

บริษัท Mattel Bangkok Co., Ltd.

ที่อยู่บริษัท

เงินเดือน สำหรับสมาชิกเท่านั้น

ลักษณะงานที่ทำ
• Performed internal audits to evaluate company compliance with ISO standards.
Developed and implemented audit plans and procedures to assess quality
management systems.
•
Identified non-conformities and recommended corrective actions to improve
processes.
•
Conducted risk assessments and analyzed data to ensure conformity to ISO
requirements.
•
Prepared comprehensive audit reports detailing findings and recommendations for
improvement.

ประสบการณ์ทำงานอื่นๆ
Apr 2013 - Dec 2015
TH Color Co., Ltd.
R&D Technology

Research and develop color and material
Bangkok

สถาบัน TUV NORD

หลักสูตร Quality Management System ISO9001-2015 Requirement

สถาบัน BUREAU VERITAS

หลักสูตร ISO 9001:2015 Internal Auditor

สถาบัน สถาบันวิจัยวิทยาศาสตร์และเทคโนโลยีแห่งประเทศไทย

หลักสูตร ISO/IEC 17025:2017 Requirement