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.
What you will do:
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.
How will you get here?
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
Professional certifications and training are a plus - e.g. CQA, Six Sigma, etc
