Quality Manager

Do you want to contribute to something that truly matters? At XVIVO, your expertise in quality can make a direct difference to patients around the world. As Quality Manager for our site in Lund, you will play a key role in ensuring high quality and patient safety while being part of a medical technology company in an exciting phase of rapid international growth. About the role: XVIVO is expanding geographically, developing new products and continuously strengthening the processes that support its growth. We are now looking for an experienced Quality Manager to join our Quality and Regulatory team. In this role, you will have an important local responsibility for quality, working closely with colleagues across the organization and with external partners and regulatory bodies. You will report to the Quality and Regulatory Director for Xvivo and will be based at our site in Lund. This is an opportunity for someone who combines solid medical device experience and quality expertise with strong analytical skills and a hands-on approach. You will be part of a company where quality is not simply a requirement, but a fundamental part of the mission. As Quality Manager, you will be responsible for a broad range of quality activities, including: Handling complaints, non-conformities and CAPAs, including follow-up and analysisFinal release of productsPerforming internal and partner auditsSupporting projects and product care activitiesPlanning and leading external audits, including audits by Notified Bodies and the FDAActing as the local management quality representative, with associated responsibilities Background & experience:We are looking for a quality professional with a strong background in the medical device industry and a genuine interest in working in a growing, international environment. To be successful in the role, you have: At least 5 years of experience in the medical device industryExperience in performing auditsExperience in design control, including both equipment and sterile disposablesA deep understanding of Quality Management Systems and relevant regulations and standardsProven competence and experience with ISO 13485, 21 CFR 820, MDSAP and other relevant medical device regulatory requirementsExcellent analytical skillsThe ability to work both independently and as a collaborative team playerExcellent spoken and written English About XVIVOXVIVO is a medical technology company listed on the Nasdaq Stockholm exchange, with headquarters in Gothenburg, Sweden, a production site in Lund, Sweden, offices in USA, Italy, and the Netherlands. The company is firmly rooted in medical science with its core business in organ transplantation. XVIVO is the first in the world to offer both machines and consumables for all major solid organs. We are committed to bringing innovative technology for storage, evaluation, and treatment of organs to transplant centres around the world, enabling the safe use of more donated organs and ultimately giving more patients the chance of a life-saving transplant. XVIVO combines the culture and agility of a smaller company with high international growth ambitions. At the heart of the organization is a strong belief in patient safety and the vision: Nobody should die waiting for a new organ. The company has a pragmatic, entrepreneurial culture where people are encouraged to take responsibility, find solutions and get things done. Regardless of role or position, employees share a strong focus on supporting customers and making a difference. Are you ready to take the next step and help XVIVO bring its vision to life? We look forward to hearing from you. How to applyIn this recruitment process, XVIVO is working with Academic Search International. For more information, please contact Senior Consultant Kornelia Rasmussen at [email protected] or Recruitment Coordinator Emma Dahlberg at [email protected]. You apply by clicking the “Apply now” button and submitting your CV. All information is handled confidentially in accordance with Academic Search Integrity Policy and GDPR. Please note that we can only process applications submitted through the application system.