For the Wright Medical EMEA (Europe, Middle East and Africa) headquarters in Amstelveen we are currently recruiting a
Quality Manager, who will be responsible for the adverse incidents and complaints as well as quality assurance. The
Quality Manager reports directly to the Director Regulatory Affairs, Quality Assurance and Reimbursement. 

The Quality Manager will initially be responsible for the management and coordination of customer complaints and
adverse incidents relating to all products that have been manufactured in Europe. The Quality Manager is in charge of
appropriate decision making and reporting to the relevant EMEA Competent Authorities as well as communication with the
safety teams in the parent company, in order to ensure global reporting needs are met. As the job position develops,
the Quality Manager will become increasingly responsible for the management and implementation of the Company's
planned ISO13485 Quality Management System. 

Tasks and responsibilities:
Central coordination of European Customer Complaints and Adverse Incidents 
Initiate any investigations and manage all related correspondence (manage central database)
Judging the significance of the incident and determining whether or not it is reportable
Training Group company or third party companies involved with the sales and marketing of Wright Medical Technology
products
Determining the need for product recalls, initiated and completed according to company procedures
System management and making sure that the appropriate investigative reports are generated and submitted
Forming and maintaining strong relationships with and between manufacturers in the United States and any third party
suppliers, to ensure the smooth operation of these systems
Setting up, carrying out and informing other parties on standard procedures regarding Customer Complaints, Adverse
Incidents and Quality Assurance
Developing an understanding of ISO13485 Quality Management Systems, with a view to implementing, maintaining and
auditing EMEA systems.