Requirements: English
Company: enGenome
Region: Pavia , Lombardia
Are you a Quality Assurance Specialist with experiencein IVD software? We are looking for a talented individual to joinour team and embrace the mission of enhancing medicine andhealthcare through genomics! About enGenome The impact of genomicson the future of medicine and healthcare will be massive, and ourmission is to enhance the diagnosis and treatment of geneticdiseases through the use of genomic information. Since 2016, wehave leveraged artificial intelligence (ML & GenAI) andbioinformatics to guide our development. We have brought to marketeVai and VarChat, two best-in-class solutions for identifyingcausative variants of genetic diseases and making the besttherapeutic decisions for patients. Have a look at www.engenome.comfor more information. The environment is young, energetic and fun!Main Responsabilities and Duties - Support in the writing,updating, verification and implementation of Quality Systemdocumentation in accordance with the requirements of applicablestandards. - Support in the management of product, process, system,audit non-conformities by writing supporting and follow updocumentation and involvement in internal investigation for rootcause determination. - Support in the planning, management, andmonitoring of corrective and preventive actions defined by thecompany. - Keeping the quality registrations and documentationsunder control. - Support in activities related to writing, updatingbusiness process risk analysis. - Support in internal stafftraining and gathering evidence of training. - Monitor Processesand KPI. - Communicate and cooperate with other departments. -Support auditing activities, internal or versus suppliers andperform internal Audits in accordance with the annual audit plan. -Participate to Change Management activities. - Support in definingspecific controls by product type and developing control plans on astatistical basis. - Support in optimizing business processes incollaboration with relevant technical departments Qualificationsand Skills - Degree in technical or scientific fields. - Previousexperience of at least 2 years in quality assurance. - Knowledge ofstandards and regulations applicable to the type of activity of theorganization (IVDR 2017/746, ISO 13485, ISO 9001). - Experience inquality systems audit according to ISO 13485, ISO 9001. - ISO 27001is a strong plus. - Aptitude to contact suppliers, consultant andpartners of the organization. - Inform and train the staffaccording the QMS procedure in a current edition. - Ability tointerface with the different departments of the organization. -Knowledge of Office suite. - Good written and spokenEnglish.