Quality Engineer

In this role, you have the opportunity to be part of the dedicated Quality team for the Factory Best. The Quality department of the factory Best will be reporting into the Q&R function and will have a dotted line to the Factory leader. The Quality department focusses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.

By joining this organization, you will be part of the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.

In this role you have the opportunity to be part of the team of Quality engineers

You are responsible for

• Ensuring full quality and regulatory compliance for his/ her unit(s) and Building Blocks,

• Adhering to company procedures and maintain compliance with FDA CFR regulations and ISO 13485:2016 standards,

• Performing internal audits on applicable procedures, regulations and instructions, proposes corrective measures for the audit findings and follows progress,

• Proactively participating in daily direction of his/ her unit(s) like MRB (Material Review Board), escalations (production stop), supplier meetings, daily team meetings,

• Taking charge and participate in maintaining and improving performance of products and processes via Quality tools and techniques (CAPA, DMAIC, Statistical Process Control, 8D,),

• Processing, validating and closing QNs (Quality Notifications) in SAP and particular NC (Non Conformity) documentation for non-conforming products,

• Reviewing and approving documentation before release (Device History Record, Device Master Record, Design History File).