Open for applications

Quality Assurance (QA) Officer (ISO 13485)

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About the vacancy

Quality
Quality Assurance
Starter Bachelor’s Degree (HBO, WO) Temporary to Permanent Part time 3000 - 4500 Groningen, Netherlands

About Your Next Job

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.


About Your Next Colleagues

We are looking for a true team player with an eye for our collective goals. You enjoy working together, act in the best interest of the team and the organization, and show initiative. You are loyal, engaged, and bring a healthy sense of humor to the table. You value being part of something bigger and actively contribute to a positive working atmosphere.


About Your Tasks and Responsibilities

Do you want to help build innovative medical technology that improves lives? 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 (ISO 13485 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.


About Your Skills and Experience

  • Quality Management: Manage and maintain the Quality Management System (QMS) in accordance with ISO 13485 standards.

  • Product Control: Take responsibility for the quality plan regarding incoming, in-process, and final inspections of our medical devices.

  • Documentation: Prepare quality reports and ensure that Technical Files are kept up to date.

  • Audits: Support both internal and external audits (e.g., by Notified Bodies).

  • CAPA Management: Identify non-conformities, analyze root causes, and implement corrective and preventive actions.

  • Advisory Role: Serve as the point of contact for Engineering and Production regarding quality and regulatory requirements.


About Your Benefits

  • A challenging role in a growing company with a real social impact.

  • A salary between €3.000 and €4.500 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.

  • An informal work environment with short lines of communication and passionate colleagues.


Contact person

Dirk Messemaker

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SE Factory designs EMDR equipment for EMDR therapists to help them during EMDR therapy. Our goal is to enable therapists to get the most out of the EMDR sessions while physically relieving the body. We do this based on the latest insights into EMDR. We offer both wireless models and our classic model that is controlled with a controller. Both models give access to visual, tactile and auditory stimuli when purchased as a complete set.



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