About this role
QA Officer Noord-Brabant High Tech & Medtech Growing organisation Wij vragen - QA Officer - HBO Waarom ons? - Transparante samenwerking - Persoonlijke aandacht - Professionele begeleiding For an innovative international organisation operating in medical devices and healthcare technology, we are looking for a QA Officer. The company develops medical imaging solutions, AI software and mobile healthcare solutions that support improved diagnostics and accessible healthcare worldwide. Quality, innovation and international collaboration are central to the organisation. Job Description As a Quality Assurance Officer for Medical Devices, you will be responsible for maintaining and continuously improving the Quality Management System (eQMS). You will provide support during internal and external audits and ensure that quality and regulatory documentation remains complete, up to date and compliant. In doing so, you will work closely with various internal teams. Responsibilities - Managing and improving the Quality Management System, eQMS, document control and release processes - Coordinating, supporting and following up on internal and external audits - Managing CAPAs, change controls, audit findings, supplier qualifications and training matrices - Identifying and implementing improvements to the efficiency and user-friendliness of the eQMS - Acting as process owner for quality processes and procedures - Maintaining quality and regulatory documentation, including CE/MDR and ISO certificates Job requirements - At least three years' experience in Quality Management, preferably within the medical devices sector - Experience in maintaining and improving a QMS or eQMS - Knowledge of GMP, ISO 13485, MDR and relevant quality processes - Experience with audits, CAPAs, change controls and document control is an advantage - An affinity for software as a medical device, AI and IEC 62304 - Experience with Atlassian, Jira, Confluence or Share...