质量工程师

Complaint Handling & Investigation Review, assess, and investigate customer complaints and product quality issues. Lead or support root cause investigations utilizing quality tools such as 5 Why, Fishbone Diagram, Fault Tree Analysis (FTA), etc. Ensure complaint records are documented accurately and closed within required timelines. Collaborate with Manufacturing, R&D, Regulatory Affairs, Medical Affairs, Supply Chain, and external suppliers during investigations. Post-Market Surveillance (PMS) Support the execution of Post-Market Surveillance activities in accordance with company procedures and applicable regulations. Monitor product performance through complaint trending, customer feedback, service reports, nonconformance reports, and other post-market data sources. Conduct periodic trend analysis and identify emerging quality signals or risks. Prepare PMS reports and contribute to periodic management review activities.