Sr. Quality Systems Specialist - Industrial Affairs

Becton Dickinson Medical Devices•Sparks, NV

1d•Onsite

About The Position

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.

Requirements

Bachelor's Degree in relevant field
1 year relevant experience

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.
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.