Senior Quality Assurance Specialist

We are seeking a skilled professional to enhance the diagnosis and treatment of genetic diseases through the use of genomic information. Our mission is to leverage artificial intelligence and bioinformatics to guide our development, bringing innovative solutions to market.

Main Responsibilities :

• Support in writing, updating, and implementing quality system documentation in accordance with applicable standards.
• Manage product, process, system, audit non-conformities by writing supporting documentation and involving in internal investigation for root cause determination.
• Plan, manage, and monitor corrective and preventive actions defined by the company.
• Maintain quality registrations and documentations under control.
• Support in activities related to writing, updating business process risk analysis.
• Train staff and gather 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.
• Requirements and Skills :
• Degree in technical or scientific fields.
• At least 2 years of experience in quality assurance.
• Knowledge of standards and regulations applicable to the type of activity (IVDR 2017 / 746, ISO 13485).
• Experience in quality systems audit according to ISO 13485.
• ISO 27001 is a strong plus.
• Aptitude to contact suppliers, consultants, and partners.
• Ability to interface with different departments.
• Knowledge of Office suite.
• Good written and spoken English.

This role offers an opportunity to work on enhancing medicine and healthcare through genomics, contributing to the development of innovative solutions that make a difference in people's lives.

Quality Assurance Specialist • Pavia, Lombardia, Italia