Quality Specialist

Becton Dickinson Medical Devices•Plainfield, NJ

24d

About The Position

The Quality Specialist supports the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure compliance with FDA 21 CFR 820 and ISO 13485 requirements. The role may serve as the North America Regional Site CAPA Lead, providing leadership and hands-on support for investigation management, root cause analysis, and corrective and preventive action plans. It also provides regional guidance on QMS requirements and supports continuous improvement, audits, quality metrics, and the integrity of nonconformance records. The role works collaboratively across organizational levels and may lead or support QMS activities and cross-functional projects. BD states that most roles require at least four days of in-office presence per week; remote or field-based arrangements are identified separately in a job posting. The listed primary work location is Plainfield, Indiana, with Four Oaks, North Carolina, as an additional location.

Requirements

Degree-level qualification or an equivalent combination of education and experience.

Responsibilities

Support the development, implementation, and ongoing maintenance of QMS processes in compliance with FDA 21 CFR 820 and ISO 13485.
May serve as North America Regional Site CAPA Lead, supporting CAPA investigations, root cause analysis, and corrective and preventive action plans.
Mentor and guide North America regional teams on QMS requirements, including nonconformance, planned deviations, and audits.
Contribute to continuous improvement initiatives.
Lead and facilitate monthly North America Region Nonconformance Coach meetings.
Ensure regional nonconformance and planned-deviation procedures align with global procedures and applicable regulatory and quality system standards.
Support internal and external QMS audits by preparing documentation, participating in audit activities, and driving corrective actions.
Analyze quality metrics and trend data to identify risks, systemic issues, and improvement opportunities related to nonconformances and planned deviations.
Maintain the integrity of nonconformance records, ensuring completeness, accuracy, traceability, and compliance.
Ensure consistent application of ISO 13485, FDA 21 CFR 820, and global policies and procedures across assigned QMS processes.
Build and maintain collaborative working relationships across organizational levels and support or lead QMS activities and cross-functional projects as needed.
Assist with other duties as required.