ผู้แทนฝ่ายบริหารระบบบริหารคุณภาพ / QMR
About this position
Responsibilities
• Develop, implement, monitor, and maintain quality Management system to meet applicable standards (e.g., ISO 13485, ISO 17025, ISO 14971, GMP, Thai FDA and US FDA Regulations).
• Promote quality awareness, implement, and enforce the company's QMS and regulatory requirements for the improvement of current processes, controls, and quality systems.
• Manage and lead internal and external audits.
• Drive process owners to take corrective actions to resolve problems.
• Control and update document including quality record in accordance with system requirements.
• Follow up on KPI Results and report to management including suggestions.
• Establish management review meetings.
• Process renewal and license updates in timely manner.
• Manage NC and CAPA (investigations, root cause determination, implementation, and effectiveness) to ensure they are adequately documented and addressed while ensuring timely completion of all NC and CAPA activities.
• Prepare and implement product and process risk management plans.
• Prepare and execute validation processes.
• Train and motivate employees to ensure quality standards are met.
• Maintain recall program and coordinate mock recalls.
• Manage and coordinate customer claims.
Requirements
• Bachelor's degree in science, engineering, or a related field.
• At least 5 years of experience in quality system functions or related fields would be an advantage.
• Experience in the medical device industry is preferred.
• Knowledge of GMP, ISO 13485, ISO 17025, Thai FDA, and US FDA requirements is an advantage.
• Certified Internal Auditor.
• Possess a quality mindset, strong motivation, logical thinking, problem-solving, and management skills.
• Good command of English.