Sr. Quality Systems Specialist - Industrial Affairs

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.

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.

• →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.

• 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.

• 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.

• 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.

• 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.