Job Description
<Job Responsibilities> - Receive and process customer complaints, investigate root causes, and implement corrective actions to ensure all complaints are handled within the required deadlines. - Issue and handle supplier complaints, manage corrective actions, and coordinate with suppliers on improvement activities. - Analyze data to prepare quality reports. Coordinate with other departments to address and formulate preventive measures for product quality-related issues. - Conduct internal audits; respond to external audits; manage quality system documentation to ensure compliance with relevant ISO standard requirements. - Perform detailed root cause analysis using structured problem-solving methodologies. - Maintain records and reports related to complaint handling, audit outcomes, and quality metrics. - Support continuous improvement initiatives within the Quality Management System.
Job Requirement
<Necessary Skill / Experience> - Bachelor's degree in relevant engineering fields (Chemical Engineering, Biology, Materials Engineering, Mechanical Engineering, Mechatronics, Automation, Electrical-Electronics). - Conversational English proficiency (TOEIC 600 or above) for reading, writing reports, and customer communication. - At least 7 years of experience in quality management, customer complaint resolution, and supplier complaint handling. - Hard Skills: Root cause analysis skills and quality management tools (5Why, Fishbone, FMEA, SPC, 8D); Good computer skills (Word, Excel, PowerPoint). - Soft Skills: Good analytical thinking; Proactive in work; Willingness to learn; Ability to work under pressure; Commitment to long-term association with the company. <Preferable Skill/ Experience> - Candidates with understanding of ISO systems, especially ISO 13485 and 14971, are advantageous. - Candidates with experience in the medical device field are prioritized. - Knowledge of Japanese is an advantage.