The Quality Assurance & Regulatory Affairs (QA/RA) officer ensures, under the direction of the Director QA/RA that the Quality Management System (QMS) is described, effectively implemented and maintained throughout the organisation in accordance with the Company Quality Policy and all relevant and applicable legislations and industry standards (e.g. MDR, EN ISO 13485). The QA/RA officer facilitates the promotion and awareness of applicable regulatory requirements and the QMS requirements throughout the organisation and reports to the Director QA/RA on the effectiveness of the QMS and any need for improvement. The QA/RA officer provides support in the implementation of Quality Objectives as agreed in the Management Review Meetings in order to achieve these objectives. The QA/RA Officer is responsible for the Document and record control, the supplier control, the CAPA management and change management. You'll be working on some QA related tasks and responsibilities such as planning of (internal) audits, providing support during the audit and follow up of audit findings. Also, reviewing of equipment maintenance and calibration reports and of batch manufacturing records and QC test results. Also, reviewing and evaluating of production deviations, out of specification reports and nonconforming product reports is part of the job. Thereby, you'll be working on data analysis and trend reporting of Key Performance Indicators of QMS processes. RA related activities are identification, evaluation and implementation of applicable regulatory requirements into the QMS. Also, maintaining the technical documentation and the EU declaration of conformity. Thereby, supporting activities related to the approval and registration of Medical Devices in the aimed for markets.