Customer Advocacy Generalist
Core
Review and evaluate customer complaints, maintain cGMP documentation, and support Medical Device Reporting and corrective/preventive actions for a continuous glucose monitoring device.
Role type
Quality Assurance Generalist (Medical Devices)
Builds
Complaint files, Medical Device Reports, CAPA records, and quality system documentation for CGM devices.
Domain
Medical Devices / Consumer Health Technology
Deliverable
dashboards & analysis
Required skills
Complaint investigation, cGMP documentation, Medical Device Reporting (MDR), CAPA management, data entry, regulatory compliance (ISO, MDD, 820)
Preferred skills
Post-market surveillance experience, analytical thinking
Technologies
Complaint processing systems, MDR submission portals
Responsibilities
Review and evaluate customer complaint documentation; Document and maintain complaint investigation records per international regulations; Assist with Medical Device Reporting and review returned product investigations; Write Manufacturer Incident Reports (MIR); Support internal, external, and third-party audits.
Seniority
Mid-level, hands-on IC