Summary

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.

Job description

Responsibilities

Support the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure full compliance with FDA 21 CFR 820 and ISO 13485 requirements.
May serve as a Regional Site CAPA Lead for the North America region, providing leadership and hands-on support for CAPA activities, including investigation management, root cause analysis (RCA), and development and execution of corrective and preventive action plans.
Provide mentorship and guidance to North America regional teams on QMS requirements, including Nonconformance, Planned Deviations, and Audit processes, while actively contributing to continuous improvement initiatives.
Lead and facilitate monthly North America Region Nonconformance Coach meetings to promote consistency, knowledge sharing, and effective issue resolution.
Ensure regional procedures for Nonconformance and Planned Deviations are aligned with global procedures and remain compliant with applicable regulatory and quality system standards.
Support internal and external QMS audits by preparing documentation, participating in audit activities, and driving corrective actions to ensure compliance and continuous improvement.
Analyze quality metrics and trend data to proactively identify risks, systemic issues, and opportunities for quality improvements related to nonconformances and planned deviations.
Own and maintain the integrity of nonconformance records, ensuring completeness, accuracy, traceability, and compliance with regulatory and internal requirements.
Ensure consistent application and adherence to ISO 13485, FDA 21 CFR 820, and Global policies and procedures across all assigned QMS processes.
Build and maintain strong, collaborative working relationships across all organizational levels, supporting and leading Quality Management System activities and cross-functional projects as needed.
May assist in other duties as required.

Minimum Requirement

Degree level qualification; or equivalent combination of education and experience.

Requirements

Degree level qualification; or equivalent combination of education and experience.
Proficiency in FDA 21 CFR 820 and ISO 13485 requirements.
Experience with Quality Management System (QMS) processes.
Experience with CAPA activities, root cause analysis, and corrective/preventive action plans.
Experience with Nonconformance, Planned Deviations, and Audit processes.
Ability to analyze quality metrics and trend data.
Strong collaborative working relationships across organizational levels.

Benefits

4 days in-office per week
COVID-19 vaccination required

Company overview

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.