Job Responsibilities:
• Lead and Responsible for manufacturing quality assurance including incoming quality, in-process quality, semi-finished product quality, and outgoing product quality
• Manage product inspection, customer specifications and requirements
• Drive incoming quality assurance process improvement in efficiency and effectiveness
• Engage sub-contractors to ensure the quality of parts and products and to drive quality improvement initiatives
• Be the owner of a Non-Conforming System. Collaborate with Headquarter for any system upgrade or changes.
• Perform analysis on non-conforming quality incidents and internal errors and provide recommendations to meet internal and customer requirements and expectations
• Support Customer Quality Engineering to investigate customer product complaints
• Responsible for quality KPIs and reporting to senior management
• Provide headship and consulting advice in quality matters
• Set quality strategies to drive company quality culture and quality improvements in process, product, and system
• Plan and lead manufacturing process audit
Job Requirements:
• Possess minimum Diploma/Degree in relevant subject area with 5-8 years’ experience in medical device QA
• ISO 13485:2016 certified internal auditor or with experiences will be advantageous
• Familiar with quality control tools
• Good communication/customer service skills
• Must able to communication in Mandarin & English
• Strong PC skills. Must possess strong working knowledge of Microsoft Office (Word, Outlook, and Excel)
• Required to lift over 30KG when necessary
