Oversee all aspects of the operation within the organization and collaborate with other departments to ensure smooth cross-functional communication and coordination.
Develop and implement plans to meet company goals and align with ISO 13485 standards.
Ensure adherence to ISO 13485 and other regulations, and manage regulatory inspections.
Supervise daily operations to maximize productivity and conduct risk assessments to minimize disruptions.
Track KPIs and metrics to identify improvements and optimize operations.
Build and manage vendor partnerships, negotiating contracts for quality and cost-effectiveness.
Oversee manpower planning and monitor sales achievement.
Lead projects to enhance efficiency and reduce costs, applying lean manufacturing practices.
Oversee the Quality Management System (QMS) and prepare performance reports for management.
Ensure compliance with relevant local laws and regulations, as well as company policies and procedures.
Prepare for and manage regulatory inspections and audits, and ensure corrective actions are implemented.
Manage budgets and forecasts, monitor financial performance, and implement cost-control measures.
Participate in conferences and networking events to stay updated on market trends and form partnerships.