Quality Systems Compliance Specialist Job Details | Ambu

Quality Systems Compliance Specialist Job Details | Ambu Quality Systems Compliance Specialist Skip to main content About us Jobs People Hiring Process Values View profile About us Jobs People Hiring Process Values View profile About us Jobs Our People Hiring process Values View profile Search Jobs Job Description Job Alerts Link Apply now open/close Print local Share on Twitter Share on LinkedIn Send as email Quality Systems Compliance Specialist City: Ballerup Country/Region: Denmark State: Business Area: Quality Assurance Department: Digital Quality Management Employment Type: Full-time Req ID: 10346 Quality Systems Compliance Specialist Join us in shaping the future of quality and compliance at Ambu Are you passionate about quality, compliance, and digital solutions within the Medical Device industry? Do you thrive at the intersection of Quality and IT, enjoy collaborating across functions, and want to play a key role in improving systems and processes that support patient care worldwide? If so, this could be your next career move. We are looking for a Quality Systems Compliance Specialist to join our Global Quality Management (GQM), Digital Quality Management team at our headquarters in Ballerup, Denmark. In this role, you will become part of a welcoming and highly collaborative team of Quality professionals who are passionate about supporting innovation while ensuring compliance. Together, we work across Ambu’s global organization, partnering with colleagues from Quality, IT, and the business to continuously improve the systems and processes that enable us to deliver high-quality medical devices to healthcare professionals around the world. As our new colleague, your primary focus will be within IT Quality Compliance, where you will contribute to IT system projects and continuous improvements led by Global IT. You will work closely with experienced QA IT Compliance specialists and play an important role in ensuring that our digital landscape remains compliant, effective, and fit for purpose. In addition, you will support the continuous development of our Quality Management System (QMS) by helping drive process and technical improvements across the organization. This role offers excellent opportunities to learn, grow, and broaden your expertise while working with knowledgeable colleagues who value teamwork, open dialogue, and professional development. A global role with real impact As a Quality Systems Compliance Specialist, you will enjoy a varied and dynamic workday where you can influence both Ambu's quality processes and digital systems while helping shape how we work across the organization. You will collaborate with stakeholders from multiple functions and locations, gaining broad exposure to both Quality and IT while supporting projects that have a direct impact on our business and compliance landscape. Your key responsibilities Ensure compliance oversight by participating in projects as the IT QA representative, supporting both new implementations and system optimizations. Support validation activities for IT systems, including documentation review, compliance and data integrity assessments, approvals, monitoring, testing guidance, and training. Perform QA reviews and approvals of changes related to Ambu's GxP-relevant business IT systems. Act as a trusted business partner to Global IT and other stakeholders across Ambu, providing guidance on quality and compliance topics. Maintain and continuously improve processes within the Global Quality Management Systems area. Contribute to the development and optimization of digital quality and process management solutions. What you'll bring We know that great candidates come from different backgrounds and experiences, and we do not believe in a perfect checklist. However, we imagine that many of the following describe you: You hold a relevant academic degree, such as an MSc or BSc in Engineering, IT, Life Sciences, or a related field. You have 2-4 years of experience working with digital quality systems, process management tools, or IT system validation in a regulated environment. You enjoy working in project-based environments and collaborating with Quality, IT, and business stakeholders. You have a solid understanding of quality management principles, risk-based thinking, continuous improvement methodologies, and quality frameworks such as ISO 13485. You communicate clearly and confidently with stakeholders at different organizational levels and are fluent in English, both written and spoken. You are curious, proactive, and eager to learn new things. You enjoy working both independently and as part of a team and value respectful and constructive collaboration. You are structured and organized, with the ability to prioritize effectively and drive tasks through to completion. You can balance business needs with regulatory requirements and find pragmatic solutions that support both compliance and operational excellence. Join a company where your contribution matters At Ambu, we are driven by our ambition to improve patient care and advance healthcare through innovative medical technology. As a rapidly growing international company, we rely on talented and engaged colleagues who enjoy working together across disciplines and borders. Your ideas, expertise, and contributions will play an important role in our continued success. When you join Ambu, you will become part of an international and informal work environment that encourages collaboration, development, and continuous learning. We offer exciting professional challenges, strong opportunities for personal growth, and a broad range of employee benefits designed to support your well-being and career development. Most importantly, you will join a team that is supportive, knowledgeable, and genuinely enjoys working together. Ready to join us? As an equal opportunity employer, all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. We encourage you to apply as soon as possible, as we review applications and invite candidates for interviews on an ongoing basis. If you would like to learn more about the position, please contact: Niels-Jørgen Svarrer Director, Global Quality Management Systems nisv@ambu.com Your application will be treated with full confidentiality. About Ambu Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific. For more information, please visit ambu.com or follow us on LinkedIn. Apply now SHORTCUTS See all products See all clinical evidence Find distributors Ambu addresses Contact us Research Support SHORTCUTS Financial News Job openings SOCIAL MEDIA Opens in a new tab. Opens in a new tab. Opens in a new tab. × Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. 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