Lausanne Metropolitan Area
Verification and validation of dental and medical devices Redaction of test plans Development of Design Control Traceability Matrix (DCTM) Analysis of test results & gap analysis Project support Research & Development support Knowledge of 60601-1 standard
In charge of quality topics with EMS main client (projects, new product launch, complaints, etc.). Analysis of product failure Support and improve quality system management in compliance with applicable requirements (ISO 9001, ISO 13485, etc.) and promote continuous improvement process Support any improvement project from quality perspective Promote quality system and approach in the company Participate to the Internal process for the risk management Support complaint management, corrective, and preventive action, change process and information exchange Promote non-conformity process on manufacturing and logistics sites Promote continuous improvement process
Conduct and document complaint investigations on ACURATE neo & neo2 devices in specified turnaround time Perform analysis on returned products (Identification of the most probable failure cause) Review and approve investigations completed on IC products Ensure compliance to regulatory standards and GMP Analysis of angiographic images received from the field Investigations of Non-Conformities Preparation and delivery of complaint trends at applicable review meetings Support Research & Development, Design Assurance and Operations teams
Conduct complaints investigations using SAP and EtQ Perform root cause analysis Document findings and conclusions of investigations Contribute to risk assessments Determine the need to open new CAPA Communicate product trending data to Post Market Surveillance Team Members and R&D department
Quality control on medical prosthesis in the supplier factory (shape, dimensions, roughness, …) Tests and FAI (First Article Inspection) on medical prosthesis Nonconformities causes research Inspection reports redaction FDA, ISO 9001 and ISO 13485 standards