Engineer QA

In the design transfer of medical devices

• Planning and qualification (quality/control plan) of test procedures and methods (incoming goods, in-process, final inspection)
• Creation of test instructions for incoming goods and final inspection
• Definition of in-process controls for the assembly process
• Qualification of test equipment (Test Method Validation, Gage R&R)
• Creation/moderation of process FMEAs for preventive error avoidance
• Creation of an overview of validations (Master Validation Plan)
• Development of test optimizations to ensure product quality
• Participation in all prototype, validation and pilot series construction in design transfer
• Participation in meetings with the PM team and close cooperation with the department

In error management:

• Participation in complex errors in components or processes (NC)
• Monitoring, planning and implementation of corrective and preventive measures (CAPA) in the specialist area
• Initiating quality maintenance projects and initiating corresponding measures

Cooperation with authorities, notified bodies and customers

• Supervision of auditing processes and company inspections by customers, authorities, notified bodies and other certification institutions certification institutions