Quality Assurance Specialist

Get AI-powered advice on this job and more exclusive features. Are you a Quality Assurance Specialist with experience in IVD software? We are looking for a talented individual to join our team and embrace the mission of enhancing medicine and healthcare through genomics! The impact of genomics on the future of medicine and healthcare will be massive, and our mission is to enhance the diagnosis and treatment of genetic diseases through the use of genomic information. Since 2016, we have leveraged artificial intelligence (ML & GenAI) and bioinformatics to guide our development. We have brought to market eVai and VarChat, two best-in-class solutions for identifying causative variants of genetic diseases and making the best therapeutic decisions for patients. Have a look at www.engenome.com for more information. The environment is young, energetic and fun! Main Responsibilities and Duties Support in the writing, updating, verification, and implementation of Quality System documentation in accordance with the requirements of applicable standards. Support in the management of product, process, system, audit non-conformities by writing supporting and follow-up documentation and involvement in internal investigation for root cause determination. Support in the planning, management, and monitoring of corrective and preventive actions defined by the company. Keeping the quality registrations and documentation under control. Support in activities related to writing, updating business process risk analysis. Support in internal staff training and gathering evidence of training. Monitor Processes and KPIs. Communicate and cooperate with other departments. Support auditing activities, internal or versus suppliers, and perform internal audits in accordance with the annual audit plan. Participate in Change Management activities. Support in defining specific controls by product type and developing control plans on a statistical basis. Support in optimizing business processes in collaboration with relevant technical departments. Qualifications and Skills Degree in technical or scientific fields. Previous experience of at least 2 years in quality assurance. Knowledge of standards and regulations applicable to the type of activity of the organization (IVDR 2017/746, ISO 13485, ISO 9001). Experience in quality systems audit according to ISO 13485, ISO 9001. ISO 27001 is a strong plus. Aptitude to contact suppliers, consultants, and partners of the organization. Ability to inform and train staff according to the QMS procedure in its current edition. Ability to interface with different departments of the organization. Knowledge of Office suite. Good written and spoken English skills. Seniority level Entry level Employment type Full-time Job function Quality Assurance Industries Software Development Referrals increase your chances of interviewing at enGenome by 2x. Get notified about new Quality Assurance Specialist jobs in Pavia, Lombardy, Italy . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr

Location: provincia-di-pavia, IT

Posted Date: 6/16/2025