Complaint Device Engineer

Descripción y detalle de las actividades

Complaint Device Investigation: - Handling of 1st/2nd level customer complaint device investigations to ensure timely resolution of a customer reported issue. - Ensure appropriate documentation of the investigation in the complaint file and escalation of issues to other groups as necessary. - Responsible for executing the tests according to test plan/specification. This includes: o Ensuring that each test record contains name, date, signature, software/test-setup version, clear pass/fail statement o Ensuring that each test is documented in Document Management System as part of the Design History File o Execution of tests and documentation of test results Complaint Monitoring: - Monthly monitoring of complaints for known issues abd - Provide input for monthly Quality reports, post market surveillance and risk management activities as applicable Other Quality related tasks: - Support during Internal/external Audits for backroom, SME, etc. - Assist in preparing management reviews