Sr. Engineer, Quality Assurance（高级工程师，质量保证）

该职位来源于猎聘 Primary Function of Position: Provides subject matter expertise to distribution quality compliance to GSP and labeling regulation requirements, including ERP/IT system, 3PL warehouse daily operation quality, NC handling, and facilitate on the Chinese label and IFU etc. Roles and Responsibilities: Operation Quality Management

• Be responsible for the initial qualification review of medical device products, suppliers and distributors, and conduct regular system audits for suppliers and distributors.
• Take charge of quality management for 3PL warehouses, and supervise full-cycle warehouse quality activities, including Chinese labeling application, incoming inspection, inventory management and outbound verification.
• Ensure company’s medical device distribution activities fully comply with GSP regulations, and maintain the validity of GSP qualification and relevant licenses.
• Independently respond to on-site inspections from regulatory authorities at all levels, and coordinate cross-department resources for inspection support.
• Manage acceptance judgement of non-conforming goods, nonconformance control, root cause investigation of quality issues and shipment hold execution.
• Manage compliance of medical device Chinese labels and Instructions for Use (IFU), and continuously drive process optimization and improvement.
• Provide ongoing quality compliance support to commercial teams. Quality System Maintenance
• Maintain the medical device distribution quality management system, draft and revise SOP documents to ensure full compliance with GSP requirements.
• Participate in the establishment and continuous improvement of corporate quality system, in line with GMP, ISO 13485 and other international standards.
• Lead or participate in internal and external quality audits, and drive corrective & preventive actions for nonconformities and audit findings. Post-market Surveillance
• Lead investigation, analysis and closure of post-market quality issues, including customer complaints, adverse events, product recalls and field corrective actions.
• Establish and maintain the post-market surveillance data system, and conduct regular product quality trend analysis. Educational Background
• Bachelor’s degree or above, major in medical device or related disciplines. Work Experience
• Over 8 years working experience in quality management within the medical device industry; candidates with imported medical device management experience are preferred.
• Familiar with medical device laws, regulations and standards, including Medical Device Supervision and Administration Regulation, GSP and ISO 13485.
• Hands-on experience in post-market issue handling, such as complaint investigation, adverse event reporting and product recall management.
• Relevant medical device registration experience or GMP working experience is preferred. Core Competencies
• Outstanding problem-solving ability: capable of rapid issue identification, root cause analysis and delivering effective corrective solutions.
• Strong communication skills: adept at cross-functional collaboration and able to communicate independently with regulatory authorities.
• Quick learning ability and proficient in using AI tools to support daily work.
• Solid proficiency in oral and written English is mandatory.