Thermo Fisher Scientific - Haverhill, MA
posted 3 months ago
The Engineer III, QA position at Thermo Fisher Scientific is a critical role within the Supplier Quality Management (SQM) team, focusing on ensuring the quality and compliance of suppliers and materials. This position involves supporting the onboarding process for new suppliers and materials, which is essential for maintaining high standards in manufacturing quality assurance. The engineer will be responsible for assigning, tracking, and reconciling Good Manufacturing Practice (GMP) documentation, which is vital for regulatory compliance and quality assurance processes. In addition to documentation management, the Engineer III will support various quality activities related to key processes, including Vendor/Supplier Change Notifications (VCN/SCNs) and Supplier Corrective Action Requests (SCARs). Establishing and implementing Quality Technical Agreements with suppliers is another key responsibility, ensuring that all parties are aligned on quality expectations and requirements. The role also includes constructing internal and external audits, as well as preparing for regulatory inspections, which are crucial for maintaining the integrity of the quality management system. The engineer will play a significant role in supporting supplier status changes to ensure that the Approved Supplier List is accurate and complete. This involves maintaining a comprehensive filing system for supplier quality documentation, which is essential for traceability and compliance. The position requires a proactive approach to quality assurance and a strong understanding of GMP regulations and quality system regulations, making it a vital role in the overall quality management framework of Thermo Fisher Scientific.