19 oct
|
Cardinal Health
|
Tijuana
19 oct
Cardinal Health
Tijuana
At Cardinal Health, we develop innovative products and services that make healthcare safer and more productive. Join a growing integral company genuinely committed to making a difference for our customers and communities. Administers the complete customer complaint process, including complaint intake, initial assessment, investigation assignment, follow-up, documentation, and closure in accordance with established procedures and regulatory requirements. Coordinates complaint investigation activities performed by technicians and cross-functional team members. Reviews and closes no-sample/no-lot complaints in accordance with applicable procedures. Maintains complaint-related quality databases, records, dashboards, and key performance indicators (KPIs), ensuring data accuracy, completeness, and timely updates. Provides direct support during FDA, Corporate, TUV, and other applicable regulatory or quality system audits.
Develops a detailed understanding of internal and external processes that may generate a Complaint and/or CAPA; verifies the accuracy of reported information and ensures that adequate objective evidence is available and properly documented. Coordinates the importation, receipt, tracking, and chain of custody of customer complaint samples submitted for investigation. Maintains and improves complaint-handling procedures, work instructions, templates, and internal documentation in compliance with corporate requirements, ISO 13485, FDA Quality System requirements, MDSAP, and other applicable regulations. Coordinates user training and manages technical and administrative activities associated with electronic complaint-handling and quality management systems. Supports customer complaint failure investigations, including unconfirmed failures, using structured root cause analysis and problem-solving tools such as Ishikawa diagrams, 5 Whys, affinity diagrams, fault tree analysis, DOE, and other applicable methodologies. Participates in CAPAs associated with customer
📌 Ingeniero de aseguramiento de calidad (Tijuana)
🏢 Cardinal Health
📍 Tijuana