Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

This position will be responsible for ensuring quality execution of Thermo Fisher Scientific Austin Site with respect to design & development, manufacturing, and release of Animal Health products. Additionally, this position will support implementation and maintenance of Quality Management System (QMS) with a focus on improving product quality and ensuring applicable global regulatory compliance - will work with R&D and Operations to ensure that product is developed and validated per good design practices and Quality Management system. This position will also provide quality guidance and expertise for implementation of practical process improvements (PPI) and continuous improvement initiatives.

• Provide Quality Assurance oversight throughout the life cycle of projects to ensure alignment to procedures as required by QMS
• Perform quality review and approval of procedures, reports, training documents and forms as designated by supervision
• Collaborate with product development and sustaining teams including manufacturing to implement robust quality control, improve processes and make recommendations for better practices where applicable
• Perform analysis of the external and internal product quality data
• Participate in Root Cause Corrective Action (RCCA) process to support root cause analysis, investigations and corrective actions related to product quality
• Participate in risk assessment process (FMEA)
• Participate in practical process and continuous improvement initiatives
• Perform other quality systems assignments and projects as assigned.

• Bachelor's degree in Life Sciences or engineering related field

• 5+ years of professional quality experience in Quality Assurance or Quality organization
• Experience and knowledge of regulations such as ISO 9001 and 13485, and other international regulatory requirements preferred.
• Experience in Life Sciences/IVD industry is a plus
• Dedicated, demonstrated ownership and responsibility
• Good verbal and written communication skills; must interface well with all levels of the organization
• Must have initiative and ability to manage multiple tasks with frequent interruptions while still maintaining high attention to detail and accuracy. Ability to solve process and equipment issues