Quality Systems Engineer

Job TitleWhite Plains, New YorkEssential Functions and Responsibilities Includes the Following:Ensure the delivery of high-quality department/clinical services in compliance with hospital and regulatory standards.Maintain a safe environment for both employees and patients.Monitor compliance with accrediting agencies and ensure all documentation meets required standards.Oversee staff competency, orientation, training, and ongoing education.Participate in committees, task forces, and special projects as needed.Work collaboratively with interdisciplinary teams to support hospital-wide initiatives.Foster positive employee relations and customer service while ensuring adherence to behavioral standards.Serve as a change agent to support hospital initiatives and technological advancements.Maintain effective communication within and outside the department.Analyze business and clinical workflows to optimize system functionality.Design database queries and generate reports using appropriate tools.Review and ensure compliance with the laboratory's Quality Management System (QMS).Ensure compliance with CLIA, CAP, NYS and other applicable regulatory and accreditation requirements.Review and coordinate with supervisors to develop and update Standard Operating Procedures (SOPs) to align with best practices and regulatory guidelines.Conduct internal audits and facilitate external inspections, including CAP and state health department audits.Investigate and resolve non-conformities, implementing corrective and preventive actions (CAPA).Monitor and evaluate quality control (QC) data, proficiency testing (PT) performance, and laboratory indicators.Conduct root cause analysis (RCA) for quality issues and ensure corrective actions are implemented.Review and analyze incident reports, deviations, and complaints to drive quality improvements.Ensure documentation of quality assurance activities and maintain quality records.Provide ongoing training to laboratory staff on quality policies, best practices, and regulatory updates.Work with department supervisors to organize competency assessments and continuing education to maintain staff proficiency.Collaborate with department leads to ensure adherence to quality and safety protocols.Identify opportunities for process optimization and workflow improvements.Lead quality improvement initiatives.Perform risk assessments and implement strategies to mitigate potential errors in laboratory testing.Serve as the primary liaison for quality-related communications between laboratory leadership, staff, and external regulators.Prepare and present quality performance reports to leadership.Maintain awareness of industry trends and regulatory changes that may impact laboratory operations.Compile Monthly Quality Reports to present for Medical Director review.Strong understanding of laboratory regulatory and accreditation standards (CLIA, CAP, NYS).Proficiency in quality management principles, root cause analysisExcellent problem-solving, analytical, and decision-making skills.Strong written and verbal communication skills for policy writing, reporting, and training.Ability to manage multiple projects, prioritize tasks, and work collaboratively across departments.Experience with Laboratory Information Systems (LIS) and data analysis tools.Flexible Scheduling for Audits and Off shift reviews.Perform additional duties as assigned to support departmental and organizational goals.Education & Experience RequirementsBachelor's degree in Medical Laboratory Science, Biology, Chemistry, or a related field (required).ASCP, or equivalent certification as a Medical Laboratory Scientist (MLS) or Medical Technologist (MT), NYSDOH license (preferred).Minimum of 3-5 years of clinical laboratory experience, with at least 1-2 years in a quality or compliance role.White Plains Hospital Medical Center is an equal employment opportunity employer. White Plains Hospital Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.