Quality Specialist

Job Summary The Quality Specialist supports development, implementation, and maintenance of the Regional Quality Management System. The individual in this role must work cross‑functionally both horizontally and vertically within the organization. Responsibilities Execute and maintain the North America Quality Management System (QMS), with primary ownership of document control and training programs. Lead development, implementation, and sustainment of QMS processes to ensure compliance with FDA 21 CFR 820, SOR/98‑282, and ISO 13485 requirements. Serve as a key resource for CAPA investigations, root cause analysis, data analysis, and continuous improvement initiatives, driving effective corrective and preventive actions. Partner cross‑functionally to train, guide, and support teams on QMS requirements, audit readiness, and continuous improvement practices. Actively contribute to CAPA reviews and Management Review meetings, providing insights and tracking progress of quality system performance. Support leadership in coordinating and executing quality‑related projects and system enhancements. Build and maintain strong cross‑functional relationships, enabling collaboration across all levels while leading or supporting end‑to‑end QMS activities and initiatives. Required Qualifications Bachelor of Arts (BA), Bachelor of Science (BS) in a related field and/or 4‑years related job experience. Some travel may be required. Knowledge and Skills Strong conceptual knowledge of quality management systems and industry‑related regulations (FDA 21 CFR 820, ISO 13485, SOR/98‑282). Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness. Ability to implement processes and systems. Ability to apply a systematic and analytical approach to problem solving. Ability to create and present material, adjusting to the level of the audience. Develop solutions to routine assigned activities of moderate scope & complexity. Ability to influence without authority coupled with ability to work collaboratively and effectively communicate with peers and management across all functions. May function in a project leadership role. Will interface with internal or 3rd party audits (e.g., FDA, Notified Body). Considered functional level subject‑matter expert in assigned areas of quality systems. Vaccination Requirement For this role, 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. Location USA, NC – Four Oaks Work Shift Standard business hours across the region (details on the career site). Salary Range $95,900.00 – $153,400.00 USD Annual Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr BD