Job Description
<Job Responsibilities> - Perform in-depth technical analysis of product nonconformities, customer feedback, and audit observations to determine root causes. - Create, execute, and verify robust Corrective and Preventive Action (CAPA) strategies to eliminate repeat issues. - Develop, maintain, and revise quality-related technical documents, including inspection methods, work instructions, and quality control plans. - Lead or assist with process validation, equipment qualification, and software validation in compliance with regulatory requirements. - Evaluate quality and process performance using statistical analysis to detect trends, assess effectiveness, and recommend improvements. - Partner with R&D during new product development to embed quality and manufacturability principles from the earliest design stages (DFM/DfQ). - Deliver technical quality support to manufacturing teams to rapidly and accurately resolve complex production issues. - Contribute to design reviews and change control activities by assessing potential impacts on product quality. - Assist in planning for and participating in internal audits as well as customer or regulatory audits. - Train and mentor staff on new quality procedures, analytical tools, and core quality assurance concepts. - Other tasks as assigned.
Job Requirement
<Necessary Skill / Experience > ・Min. Bachelor's degree in Engineering ・Min. High Conversational English proficiency (used to reporting) ・Min. 3 years as Quality Engineer in Medical Equipment Manufacture company and proficient in root cause analysis methodologies and quality tools (FMEA, 8D, Pareto Chart, Fishbone, etc) ・Knowledge on implementing ISO 13485, FDA 21 CFR Part 820, and ISO 14971 (Risk Management). ・Strong analytical mindset, systematic, detail-oriented, and solution-driven.