Sr. Quality Systems Specialist - Industrial Affairs
BDNow Job ID R-556299 Category Quality Location Sparks, Maryland As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Join a global quality organization where you will play a critical role in managing quality systems, regulatory documentation, animal origin compliance, and customer quality support activities. This position partners with customers, suppliers, government agencies, and internal stakeholders worldwide to ensure product compliance, supply continuity, and regulatory readiness. Responsibilities Manage and maintain animal origin quality systems, specifications, databases, certifications, and traceability documentation. Develop, review, and maintain Quality System procedures and technical documentation related to animal and non-animal origin controls. Serve as a subject matter expert for animal origin compliance, supplier documentation, and customer-facing quality reports and certificates. Provide documentation, technical information, and on-site audit support to industrial customers to meet quality and regulatory requirements. Partner with U.S. and international government agencies to ensure required permits, certificates, and documentation are in place to support global import and export activities. Interpret regulations, standards, and quality system requirements to solve complex quality and compliance challenges. Investigate issues, analyze data, and implement solutions related to quality systems, supplier management, CAPA, training, product support, vigilance, and recall activities. Collect, review, trend, and analyze quality data using enterprise systems and complex databases to support quality and business objectives. Create and maintain quality metrics related to animal/non-animal origin materials and supplier performance. Quality & Compliance Leadership Manage EDQM TSE Certificates of Suitability. Manage Customer Quality Agreements and ensure compliance with customer requirements. Support Cold Chain and China GSP compliance inquiries. Maintain origin specifications for animal, plant, GMO, and other sourced materials, as applicable. Support the maintenance of USDA, CDC, import/export permits, transport permits, and related certifications. Manage AOAC-RI certifications for designated products, when applicable. Support management of Design History Files (DHFs) for applicable products. Customer & Audit Support Respond directly to customer quality and regulatory inquiries, providing accurate and timely documentation. Deliver a high-quality customer exp…