Elliquence
Baldwin, NY
Quality Management Systems Supervisor Job Summary The Quality Management Systems Supervisor will oversee the development, implementation, and maintenance of the organization’s Quality Management System (QMS) to ensure compliance with industry regulations and standards (ISO 9001, ISO 13485, AS9100). Reporting to the Director of Quality Affairs, this individual will drive continuous improvement, support in leading in internal/external audits, manage CAPA processes, and provide cross-functional training to enhance quality awareness. Key Responsibilities Manage the QMS structure, ensuring all policies, procedures, and Work Instructions (SOPs) are compliant with regulatory requirements and align with company strategic goals. With guidance from the Quality Affairs Director, lead both internal and external audits (customer, registrar, regulatory), coordinate audit finding responses, and verify the effectiveness of corrective actions. Lead root cause analysis (RCA)...