QA/RA Specialist

RaySearch develops innovative software solutions to improve cancer care. Approximately 1,000 clinics in more than 40 countries utilize RaySearch software to enhance treatments and quality of life for patients. Founded in 2000, RaySearch is listed on Nasdaq Stockholm. Our headquarters is located in Stockholm, with subsidiaries in the US, Europe, and the Asia-Pacific region. Today, we employ over 400 individuals who share a common vision of advancing cancer care through innovative software. Our exceptional staff is crucial to our success, and we offer a fantastic working environment in modern offices, along with flexibility and excellent opportunities for development. We believe in equal opportunities, value diversity, and actively work to prevent discrimination. Do you want to enhance the care of cancer patients by introducing new software medical devices to Europe and other markets? Join RaySearch and our QA/RA team and contribute to making the best cancer treatments available to patients worldwide. The position is on-site at our office in Stockholm, starting in November 2025. About the role As one of our QA/RA Specialists, you will join a team of ten dedicated colleagues. The role requires prior experience in maintaining Quality Management Systems (QMS), including document management, CAPA management, and change management. Proven experience in planning and successfully leading a QMS migration project is essential. The QA/RA team is central to the company’s operations, responsible not only for the QMS but also for product market clearances, vigilance, and internal and external audits. Since the pandemic, the team has expanded from seven to twelve members and is expected to continue growing. As a QA/RA Specialist, you will report to the Quality & Regulatory Affairs Director and be involved in all areas of the department. Your main tasks: • Manage the project for transitioning our QMS from one digital platform to another. • Oversee the CAPA process and coach the organization in managing individual CAPAs. • Assist our IT department in validating tools that support the QMS and in general IT maturity. • Manage internal audits, external audits, and inspections. This role presents a great opportunity for you to contribute to the care of cancer patients by enabling new software innovations to be quickly and reliably supplied to markets worldwide. You will interact with all departments at our headquarters and work closely with an international team eager to share knowledge. Your profile To succeed in this role, you must work in a very structured and meticulous manner. You should have an interest in QMS-related tasks (e.g., document management, CAPA management, change management, and tool validation) and experience in project management. You adapt to changing conditions and possess strong communication skills. It is essential to be well-organized while remaining flexible when necessary. You recognize the importance of written processes and instructions and take the initiative to address any gaps. You can work independently and enjoy sharing your knowledge with colleagues. Skills and experience: • Knowledge of ISO 13485, MDR, or QSR • Project management experience • Flexibility • Meticulousness • Structured approach • University degree or equivalent • Proficient in English at a high business level Fluency in business English and experience in the medical device software industry are required. Our Culture The culture at RaySearch is the driving force behind our organization, where everything we do is fueled by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their fields, driven by a relentless focus on solving problems—no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment that fosters openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities such as ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we provide morning and afternoon fika every day. Our rooftop terrace also offers a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes with a competitive compensation and benefits package. Application Please apply for the position through the application form below. Selection and interviews will be ongoing. We do not accept applications via email.