Quality Systems Post Market Staff Lead

Job description

Job Description Summary This position ensures robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups. This role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross-functionally to scope field actions, collaborates and provides feedback on the Post Market Risk Assessment and Health Hazard Evaluation (HHE) process and facilitates its completion, and delivers data-driven insights for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and leverages analytics to monitor KPIs, identify systemic issues, and implement timely, validated solutions that uphold product safety, compliance, and customer trust Job Description: We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and market...