About this role
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company’s Quality Management Systems, ensuring adherence to domestic and international regulations and company policies. Quality Systems and Regulatory Compliance: Know and apply the Quality System and any appropriate Federal and International standards (FDA, ISO 13485, MDSAP, EU MDR, etc.) Provide leadership and strategy for the team in the overall administration and maintenance of the QMS processes, ensuring alignment with organizational goals. Ensure that Quality Management Systems documentation meets the required guidelines for maintaining FDA compliance and ISO/EC/MDR certification. Support the strategic initiatives of the company to achieve and maintain regulatory compliance. Corrective and Preventive Action: Oversees CAPA system, including maintenance, development and system validation. Develops and facilitates continuous training and development for the CAPA process, including root cause analysis and verification of effectiveness. Responsible for the reporting of CAPA system KPIs during Quality Systems Governance and Management Review. Operates as lead Subject Matter Expert during internal/external audits and inspections.. Product/Process Nonconformance: Oversees NC system, including maintenance, development and system validation. Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions. Operates as lead Subject Matter Expert during internal/external audits and inspections. Product Corrections and Removals: Oversees the process for product event escalations, health hazard evaluation, and execution of product corrections and removals. Provides guidance and drives cross-functional collaboration to make timely decisions, based upon product risk. Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions. Operates as lead Subject Matter Expert during internal/external audits and inspections. Training and Cross-Functional Responsibilities: Oversees the Learning Management Solution (LMS), including maintenance, development and system validation. Develop training and competency solutions to meet the needs of the company and its Quality Management System. Monitors Quality Systems training curricula for completeness, appropriateness and execution. Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review. Operates as lead Subject Matter Expert during internal/external audits and inspections. Data Analytics & Reporting Responsibilities: Assist with the development of training materials and documentation to ensure effective dissemination of knowledge to team members and stakeholders. Responsible for compiling process data for presentation during Quality Systems Governance and Management Reviews. Facilitates Quality Systems Governance and Management Review meetings in accordance with company procedures.