Ingeniero de Calidad De Quejas
Core
Manages the end-to-end customer complaint lifecycle, including intake, investigation coordination, root cause analysis, and regulatory reporting for medical devices.
Role type
Senior Quality Engineer (Customer Complaints)
Builds
Investigated complaint cases, CAPAs, and regulatory audit responses
Domain
Medical Devices / Healthcare Quality & Regulatory Compliance
Deliverable
client delivery | dashboards & analysis
Required skills
Root cause analysis, complaint investigation, regulatory compliance (FDA/ISO 13485), data trending, technical writing, cross-functional collaboration
Preferred skills
eQMS platforms (TrackWise, Salesforce, SAP), statistical analysis tools (DOE, Ishikawa), laboratory testing
Technologies
TrackWise, Salesforce, SAP, eQMS platforms
Responsibilities
Administer complete customer complaint process from intake to closure; Coordinate investigation activities with technicians and cross-functional teams; Maintain quality databases and KPI dashboards; Support regulatory audits; Perform sample inspection and technical analysis; Draft customer response letters and investigation summaries; Analyze complaint data for trends and systemic issues.
Seniority
Mid-Senior, hands-on IC