Executes quality assurance programs focused on recalls, complaints, regulatory reporting, audits, change control, SOP updates, and quality issue resolution. Conducts root cause analyses, tracks quality metrics, supports inspections, prepares regulatory responses, and advises stakeholders on compliance. Mentors junior employees and assists with training while supporting the Quality Assurance Manager on complex quality matters.

Lead and manage site quality operations ensuring regulatory compliance and patient safety. Develop and implement quality systems, oversee audits and responses, train and manage quality staff, conduct Site Quality Management Reviews, report KPI metrics, identify trends, and make product release decisions.