Requirements: English
Company: enGenome
Region: Milan , Lombardy
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!
About enGenome
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 Responsabilities 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 documentations 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 KPI.
- 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 to 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, consultant and partners of the organization.
- Inform and train the staff according the QMS procedure in a current edition.
- Ability to interface with the different departments of the organization.
- Knowledge of Office suite.
- Good written and spoken English.