Manager Quality Systems - EDMS, Patient Safety and Change Control (On Site)

Job description

Purpose and Scope This position is responsible for providing oversight and continuously improving the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, 21 CFR Parts 210/211, and EU MDR. This role includes ownership of key processes such as document control, customer complaints, and change control, ensuring that these areas meet regulatory requirements and support the organization's commitment to quality. General: - Participate on cross-functional teams, representing Quality Systems, to drive shared understanding of quality requirements and continuous improvement. - Drive QMS effectiveness using data and metrics across CAPA, document/records management, training, change control, nonconformance/deviations, and management review. - Maintain current and acquire new knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches. - Integrate Tolmar’s core values into team goals and decision-making. - Develop and implement processes, procedures, forms, work instructions, and tools to support compliance systems. - Suppor...