Quality Specialist, Complaints

A Quality Specialist, Complaints supports the Quality organization by conducting technical investigations into customer complaints and ensuring regulatory compliance within a medical device manufacturing environment at Baxter. The role involves analyzing complaint data, performing root cause analysis using specific methodologies like Fishbone diagrams, and collaborating cross-functionally with Manufacturing, Engineering, and Regulatory Affairs to maintain quality management systems. Key duties include documenting investigation findings, drafting compliant customer response letters, and supporting CAPA activities to uphold FDA and ISO 13485 requirements.