DUTIES AND RESPONSIBILITIES

• Take care of Quality systems for medical devices and food safety (60%)
• Monitor all established and implemented activities regarding quality systems for medical devices and food safety.
• Report the result of the quality system for medical devices and food safety performances.
• Lead the audit both internal and external of quality systems for medical devices and food safety.
• Lead the quality control and releasing process in the co-packing facility.
• Establish the quality management system plan and manage to complete all activities.
• Ensure temperature monitoring and compliance.
• Review and ensure compliance with related laws and regulations.
• Take care of calibration, pest control, and cleaning programs whole the assigned site.
• Lead all validation and qualification activities.
• Coordinate the management review for all systems (quality system for medical devices and food safety)
• Oversee the security control performance on the site.
• Lead for the risk assessment in terms of quality systems for medical devices and food safety.
• Ensure the monitoring and measurement are done as planned e.g., temperature monitoring, water, and wastewater analysis
• Promote the quality system for medical devices and food safety awareness (20%)
• Plan and ensure the communication of the quality system for medical devices and food safety.
• awareness via different channels e.g., training, toolbox talk, etc.
• Plan and ensure for emergency responses and BCP
• Follow up of the investigation, corrective action and follow up of NC, CAR/PAR (20%)
• Summarize, analyze on issues regarding to quality system for medical devices and food safety e.g., Non-Conformity (NC), CAR/PAR
• Follow up on the effectiveness and closure of NC and/or CAR/PAR

KNOWLEDGE AND SKILL REQUIREMENTS

• At least 05 years of working experience at QA/Quality Assurance position(s) in medical devices or food manufacturing.
• Experience in logistics industry is a big plus.
• Knowledge of quality systems for medical devices and food safety and management systems e.g., ISO9001, GHPs, ISO13485, ISO14971, etc.
• Native Thais level, fluent English
• Skills in management and planning
• Experience in the implementation of any international standards
• Able to operate SAP system