Senior Quality Systems Specialist - Genomics

beBeeQualityAssurance; Pavia; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading company in genomics is looking for a Quality Assurance Specialist to enhance their IVD software. The successful candidate will support quality documentation, manage audits, and ensure compliance with standards. This role requires a degree in a technical field and at least two years of related experience, making a significant impact on patient health through innovative genomic solutions.

Competenze

• Minimum 2 years experience in quality assurance.
• Knowledge of IVDR 2017/746, ISO 13485 regulations.
• Experience in quality systems audit is essential.

Mansioni

• Support writing and implementation of Quality System documentation.
• Manage product and process non-conformities and conduct investigations.
• Plan and monitor corrective actions and internal audits.

Conoscenze

Quality Assurance

Audit

Documentation

Risk Analysis

Communication

Statistical Analysis

Team Collaboration

Regulatory Knowledge

English

Formazione

Degree in technical or scientific fields

Strumenti

Office suite

Descrizione del lavoro

At enGenome , we are looking for a Quality Assurance Specialist with expertise in IVD software to join our team. We embrace the mission of enhancing medicine and healthcare through genomics.

About Our Mission

The impact of genomics on the future of medicine and healthcare will be massive, and our aim 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.

Main Responsibilities and Duties

• Support the writing, updating, verification, and implementation of Quality System documentation according to applicable standards.
• Manage product, process, system, audit non-conformities by creating supporting documentation and participating in internal investigations to determine root causes.
• Plan, manage, and monitor corrective and preventive actions defined by the company.
• Keep quality registrations and documentation under control.
• Support activities related to writing, updating business process risk analysis.
• Support 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 defining specific controls by product type and developing control plans based on statistical data.
• Collaborate with relevant technical departments to optimize business processes.

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 organization's 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.
• Inform and train staff according to QMS procedure.
• Ability to interface with different departments.
• Knowledge of Office suite.
• Good written and spoken English.