About the CompanyOur client is a dynamic start up medical software company on a mission to change how orthopaedic surgeons plan knee replacement surgery. Their AI-powered planning tool gives surgeons a faster, more precise view of what they are dealing with before a single incision is made. The startup team is small, the product is moving fast, and the regulatory ambition is serious. The company has already selected a notified body for its EU MDR submission and is pursuing FDA market access. Quality is not an afterthought here; it has been a strategicpriority from day one. The office is in Antwerp (Berchem), one minute from the station. The culture is direct, transparent, and built around real collaboration between engineers, orthopaedic surgeons, data scientists and quality professionals working side by side. The way of working is in weekly sprints with an agile development approach.About the RoleAs quality assurance specialist will work directly with the Chief Operating Officer to support the rollout and ongoing operation of the Quality Management System. This is a hands-on position with real ownership from day one. You will be the person who makes sure the quality infrastructure keeps running, the documentation is in order, and the team is audit-ready as they move toward its first regulatory submissions. This is not a background support role. The company is building something exciting, and quality is central to that build. You will have direct visibility into product development, work alongside software engineers, data scientists and clinical team members, and grow into a genuine partner on quality and regulatory matters over time.ResponsibilitiesDraft, review, and maintain QMS documentation: SOPs, work instructions, forms, and recordsSupport the day-to-day operation of the software-based QMS, selected specifically for agile medical device developmentMaintain document control and ensure record-keeping meets ISO 13485 requirementsSupport internal audit preparation, conduct internal audits and regulatory submission activitiesCollaborate with the development team to integrate quality practices into the agile software cycleContribute to data quality activities, including annotation and quality checks on CT scan datasets used for AI model development and validationGrow into a broader sparring partner for the Chief Operating Officer on quality and regulatory strategyQualificationsYou bring:2 to 4 years of hands-on QA experience in the medical device industrySolid working knowledge of ISO 13485, not just theory but practical day-to-day applicationExperience writing and managing QMS documentation: SOPs, work instructions, forms, and recordsAwareness of the MDR 2017/745 regulatory frameworkA digital-first mindset and genuine openness to working with new tools, including AI-assisted workflowsStrong communication skills in English; direct, confident, and comfortable in small team discussions. Dutch would be an asset but not a must.A flexible, curious and teachable approach. You ask why, adapt, and are not wedded to the way things were done elsewhere.Preferred SkillsKnowledge of 21 CFR Part 820 (FDA) and/or IEC 62304Experience in a software medical device environment or a hardware/software combination device companyA background in a larger, structured organisation where you have seen a mature QMS in action.Pay range and compensation packageA competitive salary and benefits package in line with your experienceA direct line into the quality, regulatory and clinical leadership of a medtech company with serious backingA hybrid work model of Mondays and Fridays in the officeThe rare opportunity to shape a QMS from the ground up in a company where quality is genuinely valued at board levelA space to grow and learn