Sr. Quality Systems Specialist - Industrial Affairs

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 experience through effective communication and issue resolution. Host and manage customer audits and support audit readiness activities. Represent Industrial Affairs during customer interactions, quality reviews, and cross-functional discussions. Project & Team Leadership Represent Industrial Affairs on project teams, review boards, and cross-functional initiatives. Train and mentor associates within and outside of Industrial Affairs. Provide technical guidance and support to less experienced team members. Develop and deliver presentations to internal and external stakeholders. Lead or coordinate quality-system-related initiatives with minimal supervision. May supervise employees and assign work responsibilities, depending on organizational needs. Required Qualifications: Bachelor's Degree in relevant field 1 year relevant experience At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location USA MD - Sparks - 39 Loveton Circle Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You". Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $95,900.00 - $153,400.00 USD Annual #J-18808-Ljbffr Regulatory Toolkit