Sr. Quality System Improvement Specialist

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We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Job Responsibilities: Develop, analyze, and communicate departmental metrics, complaint trends, and actionable insights; lead recurring KPI reviews to drive data integrity, alignment, and cross-functional action plans. Drive the development, implementation, and continuous improvement of complaint handling systems, tools, SOPs, and processes to ensure efficiency, standardization, and compliance with corporate policies and regulatory requirements. Ensure timely, accurate, and compliant execution of complaint handling activities in accordance with established procedures, FDA regulations, and service level expectations; maintain audit readiness and support internal and external audits. Lead and execute strategic and operational projects, serving as a subject matter expert in complaint management, metrics, trending methodologies, and process governance. Partner with Field Assurance and cross-functional leadership to monitor and advance quality improvement initiatives, ensuring accountability, follow-through, and sustained results. Develop and update training materials for Field Assurance engaging FA SMEs, QEs, and other external partners. Conduct training for FA department new and existing employees, and contractors. Responsible for coordinating new employee and contractor's Onboarding training and schedule while working closely with FA managers/supervisors. Lead and facilitate Kaizen and PSP activities, applying structured problem-solving tools (e.g., root cause analysis, process mapping) to identify trends, reduce waste, and drive sustainable improvements. Perform additional duties and responsibilities as assigned. Education and Experience: Bachelor's degree in Science, Engineering, or related discipline, with a minimum of five (5) years of relevant technical experience. Minimum of four (4) years of experience in an FDA-regulated industry, including hands-on experience in complaint handling and investigation processes. Demonstrated professional presence, sound judgment, and a high level of work maturity. Experience with Kaizen and PSP methodologies is preferred. Experience with developing and conducting training. Knowledge and Skills: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Strong understanding of Corporate and Site Quality Systems, with the ability to implement systemic improvements that enhance processes, support Kaizen initiatives, and drive business efficiency. Proven leadership and influencing skills, including the ability to lead Kaizen events, facilitate PSP activities, and drive cross-functional alignment without direct authority. Hands-on experience in data analysis within the medical device, pharmaceutical, or biotech industry, including proficiency with tools such as Excel, Minitab, Power BI, and complaint handling systems (e.g., TrackWise). Knowledge of Medical Device complaint handling and regulatory reporting requirements. Strong analytical and structured problem-solving capabilities, including root cause analysis, process mapping, PSP methodologies, and continuous improvement tools (e.g., Kaizen, Lean principles). Excellent interpersonal, communication, and facilitation skills, with the ability to lead improvement workshops, write reports, interpret technical and regulatory information, and effectively present insights to diverse audiences. Strong critical thinking skills, including active listening, questioning, assessment, and attention to detail, with a focus on accuracy, consistency, and efficiency. Self-motivated and adaptable, with the ability to manage multiple priorities in a fast-paced, matrixed environment. Proficient in Microsoft Office applications (Excel, Word, PowerPoint, Visio) and general computer use. Ability to interpret business, technical, and regulatory documents and apply mathematical concepts such as ratios, percentages, and data visualization. Physical Demands: While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Sp

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