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Becton Dickinson

Global medical devices, lab equipment supplier

Senior Quality Systems Specialist - Industrial Affairs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSparks, MD, USA$95.9k - $153.4k /yr

About the Job

Requirements

  • A bachelor's degree in a relevant field is required.
  • At least 1 year of relevant experience is required.

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 (DHF) for applicable products.
  • Respond directly to customer quality and regulatory inquiries, providing accurate and timely documentation.
  • 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.

About the Company

Becton Dickinson

Global medical devices, lab equipment supplier

BD (Becton, Dickinson and Company) is a global medical technology company that designs, manufactures, and sells medical devices, laboratory equipment, and related services for hospitals, labs, clinicians, and biopharma partners. It operates in four segments: Medical Essentials (medication delivery and specimen management devices), Connected Care (medication management and advanced patient monitoring systems), BioPharma Systems (drug delivery systems for pharmaceutical partners), and Interventional (surgical, endovascular, urological, and critical care products). In addition to devices, BD offers connected software, analytics, clinical education, customer portals, and service programs to support its products. The company’s goal is to help healthcare providers improve patient outcomes by enabling safer and more efficient delivery of care through integrated devices, data, and services across the health ecosystem.

Company size
10,001+
Company stage
IPO
Headquarters
Franklin Lakes, NJ
Founded
1961

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