Quality System Specialist Job Details | Ambu

Quality System Specialist Job Details | Ambu Quality System 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 System Specialist City: Ballerup, DK Country/Region: Denmark State: Business Area: Quality Assurance Department: Global Quality Management Processes Employment Type: Full-time Req ID: 10312 Do you have a genuine passion for Quality and Compliance? Do you thrive in a dynamic environment where you help keep processes running smoothly and support colleagues across the organization? If so, this could be your defining moment. Join us and take your career #ForeverForward. A global role with real impact We are looking for a Quality System Specialist to join our Global Quality Management - QMS Processes team, based at our HQ in Ballerup, Denmark. You will collaborate closely with colleagues both in Denmark and at our R&D site in Augsburg, Germany. You will become part of a strong quality culture where our core values — take charge, team up, stay true — guide everything we do. Responsibilities In this role, you will enjoy a varied workday with a mix of coordination, routine tasks, and cross functional collaboration. You will gain insight into many of Ambu’s processes while ensuring that our global QMS runs smoothly and efficiently. Your key responsibilities include: Maintaining, developing, and improving global QMS processes with a focus on simplicity and usability Supporting change notifications to BSI, authorities, and MAHs related to Ambu’s QMS certificates, including archiving updated certificates Preparing and coordinating quality reporting (QMR, quarterly reports, board materials) on behalf of the QMS Processes department Holding the role as Person Responsible for Regulatory Compliance, ensuring that the conformity of the devices is appropriately checked, in accordance with Ambu’s Final Release Process. The process includes training of Release Officers, approval of Job Descriptions, and quarterly monitoring Helping the organization understand external QMS requirements and ensuring effective implementation Acting as an internal auditor and participating in corporate audits at other Ambu sites Participating in Notified Body audits and authority inspections Driving or contributing to prioritized business projects within QMS Processes Handling a variety of practical and administrative tasks that keep our quality system running seamlessly This is a role for someone who enjoys being the central coordinator — the person others rely on for structure, clarity, and follow through. Experience And Passion We imagine your background includes: A relevant academic degree At least 4 years of experience in a medical device quality organization Solid knowledge of relevant medical device regulations (ISO 13485, EU MDR, MDSAP, UK MDR) Experience as an internal auditor A strong interest in quality and a collaborative, business partnering mindset As a person, you are outgoing, structured, and confident in communicating quality requirements. You enjoy supporting colleagues, facilitating processes, and ensuring that things are done the right way. You are self driven, proactive, and comfortable taking ownership. You value good collaboration, stay open minded, and keep a positive outlook even when things get busy. Ambu is a global company, and English is our corporate language. You should therefore be able to communicate clearly in English, both verbally and in writing. If you have any questions about the position, please contact Head of QMS Processes, Mette Rittmeyer, at mrit@ambu.com. Please note that due to the upcoming summer holiday period, the recruitment process may take slightly longer than usual. We expect to begin the interview process at the beginning of August. Ambu - a visionary and international workplace where your efforts matter Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment. We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development. 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. 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