2 jobs found in Baldwin

Quality Management Systems Supervisor The Quality Management Systems (QMS) Supervisor is responsible for overseeing the development, implementation, and ongoing maintenance of the organization's Quality Management System to ensure compliance with applicable regulatory and industry standards. This role partners closely with cross-functional teams to promote a strong culture of quality, support audit readiness, and drive continuous improvement initiatives across the organization. Reporting into Quality leadership, this individual plays a hands-on role in audit management, CAPA oversight, document control, and QMS performance monitoring while serving as a key resource for quality training and compliance guidance. Key Responsibilities Own and maintain the Quality Management System structure, including policies, procedures, SOPs, and work instructions, ensuring alignment with regulatory requirements and organizational objectives Support and lead internal and external audits...

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) for...