Quality Assurance (QA) Officer (ISO 13485), Groningen

About the Company

Our EMDR equipment is used worldwide—and we manufacture the vast majority of it ourselves. We are a close-knit organization of 25 colleagues with short communication lines, where collaboration is key and everyone knows each other. Do you want to help build innovative medical technology that improves lives?Role Overview

As a Quality Assurance Officer at SE Factory, you are the guardian of our standards in a dynamic environment where R&D and production meet. You ensure that every product complies with strict laws and regulations (ISO13485 and MDR). You won’t just be “checking boxes.” You will actively contribute to process improvement and foster a strong culture of quality awareness on the work floor. Responsibilities

Manage and maintain the Quality Management System (QMS) in accordance with ISO13485 standards. Take responsibility for the quality plan regarding incoming, in-process, and final inspections of our medical devices. Prepare quality reports and ensure that Technical Files are kept up to date. Support both internal and external audits (e.g., by Notified Bodies).Identify non-conformities, analyze root causes, and implement corrective and preventive actions. Serve as the point of contact for Engineering and Production regarding quality and regulatory requirements. Benefits

A salary between€3000 and €4500 gross per month (based on experience). Holiday allowance and a solid pension scheme (compliant with the CAO Metaal en Techniek). Opportunities for training and courses in the field of QA/RA. Work Environment

An informal work environment with short lines of communication and passionate colleagues. A challenging role in a growing company with a real social impact.

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