Staff Quality Systems Specialist I

Job Overview Becton, Dickinson and Company (BD) is one of the largest global medical technology companies, advancing health worldwide. The role of Site Quality Lead focuses on ensuring compliance, continuous improvement, and effective collaboration across cross‑functional teams at a BD manufacturing site. Responsibilities Develops applicable Site / Unit procedures and work instructions and update Unit level procedures and policies. Serves as Site CAPA Leader, acting as a subject‑matter expert on CAPA content and Trackwise use. Leads site CAPA Board meetings and coordinates with the World Wide CAPA Board to ensure timely completion and escalation of CAPA activities. Acts as the site Audit Manager, collaborating with the PS Internal Audit Program Manager to assess risks and ensure audit requirements are met. Ensures systematic execution of all required internal, external (FDA, ISO, etc.), and customer audits. Supports pre‑ and post‑inspection activities, including hosting, logistics, coaching of subject‑matter experts, record review, and tracking of audit responses and closures. Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations), providing subject‑matter expertise on QN content, process, and electronic tool utilization. Supports end users in meeting timely completion of QN related activities. Leads or supports problem‑solving and root cause analysis activities as needed, and coaches cross‑functional teams as a problem‑solving subject‑matter expert. Tracks trends from quality data sources (CAPA, audits, QNs, etc.) and analyzes and reports on metrics. Assists with Management Review content development and related activities. Maintains Site and World Wide Quality Systems and supports continuous improvement initiatives. Collaborates with cross‑functional partners such as Quality Engineering, R&D, Operations, Medical, and Marketing to obtain input into policy and procedure development and resolution of quality issues. Qualifications At least 8 years of experience in the medical device, biologic, pharmaceutical, or diagnostic industry. Knowledge of US and International regulations and standards applicable to medical devices, including 21CFR820, ISO 13485, MDD/MDR, and MDSAP country requirements. Strong communication, organizational, and interpersonal skills. Ability to perform multiple tasks, prioritize workload, and work independently with minimum supervision. Effective analytical, technical, and problem‑solving skills. Effective meeting and presentation skills. Ability to perform and host internal and external audits. Collaborative ability to work in teams to obtain desired results. Education BS degree in Engineering, Science, or a related discipline. Location & Compensation Primary work location: Franklin Lakes, New Jersey, USA. The position requires a minimum of 4 days in‑office per week; remote or field‑based arrangements may apply to certain roles. Salary range: $135,500.00 – $216,800.00 USD annually. The actual offer will depend on role level, experience, and location. EEO Statement 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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr Becton Dickinson