Quality Engineer

Aantal uren: 

We are looking for a Quality Engineer for 32-40 hours a week. 

What are you going to do?
You will be part of the Quality Department and report to the Quality Manager. You work closely together with the product managers. Your main responsibilities are:
• Responsible for preparation and maintenance of the technical files in support of CE marking of existing and new medical devices
• Assessment of production methods and quality processes at suppliers/ distributors
• Root cause analysis through quality data analysis and failure analysis process and implementation of the corrective and preventive actions
• Perform internal/external audits of products and (production)processes
• Demonstrating compliance of the quality processes during audits and inspections by our Notified Body, customers and Regulatory Authorities
• Execute the Post Market Surveillance Plan

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