Quality System Specialist II

Key Responsibilities Accountable for setting own work direction and completing work tasks. Under the direction of the Complaint Manager, handle activities and procedures associated with Specimen Management product complaints, including supervising the processing of customer complaints, maintaining complaint files, responding to customers, and producing quality reports. Provide mentorship and education regarding customer complaint processing, MDRs, complaint reporting, and regulatory compliance. Fill out decision trees when needed, after appropriate complaint investigation, and file MedWatch reports after Leader review and approval. Generate MDR reports in accordance with BD procedures and FDA regulations. Qualifications Develop, implement, and follow procedures to ensure timely and accurate receipt, logging, analysis, and response to customer complaints, reviewing all complaints for validity and ensuring compliance with policies and procedures. Provide mentorship, review, and generate MDR reports utilizing BD procedures and FDA regulations. Contribute to the business-wide quality strategy and quality objectives. Maintain systems to supervise and facilitate timely investigations and close out of open complaints, ensuring they are completed promptly. Supervise and communicate significant complaint trends, adverse events, and other pertinent reports. Provide and analyze organizational quality metrics to assess the efficiency of quality system improvements; provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports. Interact with health‑care workers, consumers, and other professionals regarding product quality concerns as needed. Ensure that customer complaint investigation procedures follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and resourcefulness by leading assignments in accordance with project priorities and altering the course of action when vital. Maintain privacy and confidentiality of patient records and private information. Represent Specimen Management on cross‑business quality system teams. Partner with other quality professionals to address recurring issues identified organization‑wide. Provide ongoing education and training of staff on product usage, common complaint scenarios, data capture, regulatory requirements and assessment. Education and Experience BS degree in Medical Technology, Biomedical Engineering or related healthcare/engineering field or equivalent level of experience. 2–3 years of experience in a health‑care setting where BD or similar products are used (clinical labs, hospitals, ICUs, healthcare delivery settings). 3 years or more experience in complaint handling, medical device reporting, FDA regulations, GMP, quality systems, and applicable clinical or laboratory functions. Solid understanding of regulatory standards applicable to the design of medical devices (FDA QSR 21 CFR 820, ISO 13845, ISO 14971, IEC 60601) and collateral standards. Knowledge of product failure modes; competence in mechanical and functional risk assessment. Skills Strong analytical, deductive reasoning, and listening skills. High level of problem identification, analysis, and formulation of conceptual, technical, and business solutions. Ability to manage ambiguity. Clear and accurate communication. Strong product knowledge of clinical application usage and/or manufacturing process. Effective analytical, technical, and problem‑solving skills. Strong project management skills. Equal Opportunity Employment 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. Primary Work Location: USA, NC – Durham – Davis Drive #J-18808-Ljbffr BD (Becton, Dickinson and Company)