高级质量工程师 - 医疗设备

Position Summary The Senior Quality Engineer will play a key role in driving product quality, reliability improvement, and customer satisfaction for the ULT product portfolio. This role will lead complex quality investigations, reliability improvement initiatives, customer quality escalation management, and cross-functional quality improvement programs while supporting the long-term development of Suzhou as a global ULT manufacturing and capability hub. Key Responsibilities Lead product quality improvement initiatives across manufacturing, suppliers, and field performance. Analyze quality trends and drive systemic corrective actions. Support quality readiness for product transfers, capacity expansion, and new product introduction activities. Lead customer complaint investigations and resolution activities. Drive RCCA and CAPA implementation. Support global customer quality escalations and warranty reduction initiatives. Improve customer satisfaction through proactive quality improvements. Lead failure analysis and reliability improvement projects. Support validation and reliability testing activities. Analyze field failures and identify long-term improvement opportunities. Partner with Engineering and Validation teams to improve product robustness. Support qualification and performance improvement of critical suppliers. Lead supplier quality investigations and corrective actions. Participate in supplier audits and risk assessments. Utilize AI and digital tools to accelerate root cause analysis and quality investigations. Apply data analytics to identify quality trends and improvement opportunities. Support development of quality dashboards and digital quality reporting systems. Build digital knowledge repositories for quality and reliability learnings. Qualifications Bachelor's degree or above in Engineering or related discipline. 8+ years of experience in Quality Engineering, Reliability Engineering, or Product Quality. Experience in Medical Device, Laboratory Equipment, Refrigeration, HVAC, Compressor, or related industries preferred. Strong problem-solving skills using 8D, RCCA, FMEA, DOE and statistical analysis tools. Experience with ISO13485 and regulated environments preferred. Familiarity with AI-enabled engineering tools, Power BI, Minitab, Python, or equivalent analytics tools preferred.