The Factory Manager will be responsible for ensuring efficient production, regulatory compliance, product quality, operational excellence, workforce development, and continuous improvement across all manufacturing activities. The successful candidate will drive productivity, optimize resources, maintain compliance with applicable quality and regulatory requirements, and support the company's strategic growth objectives. Key Responsibilities: Manufacturing Operations Management Plan, organize, direct, and control all factory operations to achieve production targets and business objectives. Ensure efficient utilization of manpower, machinery, materials, and resources. Monitor production performance and implement corrective actions to improve productivity and efficiency. Develop and execute production plans to meet delivery schedules. Optimize manufacturing processes to reduce waste, downtime, and operational costs. Ensure uninterrupted production while maintaining the highest quality standards. Quality and Regulatory Compliance Ensure compliance with applicable regulatory requirements governing medical device manufacturing. Maintain and support Quality Management Systems in accordance with ISO 13485 and ISO 9001 requirements. Ensure products consistently meet the required specifications, quality standards, and regulatory requirements. Support and maintain compliance with CE Marking requirements and related conformity assessment processes. Collaborate closely with Quality Assurance and Regulatory Affairs teams regarding audits, inspections, non-conformities, corrective actions, and continuous improvement initiatives. Promote a strong quality culture throughout the organization. Leadership and People Management Lead, motivate, and develop production, maintenance, engineering, warehouse, and support teams. Establish performance objectives and monitor departmental performance. Foster a culture of accountability, teamwork, safety, and operational excellence. Identify training needs and support employee development and succession planning. Ensure compliance with company policies, procedures, and labor regulations. Health, Safety, and Environmental Management Ensure compliance with occupational health, safety, and environmental requirements. Promote a proactive safety culture and ensure safe working practices across all departments. Lead risk assessments and implement preventive and corrective actions. Investigate incidents and ensure appropriate corrective actions are implemented. Support compliance with ISO 14001 and ISO 45001 management system requirements. Maintenance and Engineering Management Oversee preventive and corrective maintenance programs. Ensure maximum equipment reliability, availability, and operational efficiency. Coordinate equipment upgrades, installations, and improvement projects. Ensure proper calibration, validation, and maintenance of production equipment and utilities. Supply Chain and Inventory Coordination Work closely with Procurement, Planning, Warehouse, and Logistics teams to ensure uninterrupted manufacturing operations. Monitor inventory levels of raw materials, packaging materials, and finished goods. Support inventory optimization and cost-control initiatives. Continuous Improvement Identify opportunities to improve productivity, quality, efficiency, and profitability. Lead process improvement initiatives and operational excellence projects. Implement best manufacturing practices and performance improvement programs. Budget and Cost Management Prepare and manage factory operational budgets. Monitor manufacturing costs and implement cost-reduction initiatives. Control expenditures while maintaining quality, compliance, and operational effectiveness. Support capital expenditure planning and investment decisions. Reporting and Performance Monitoring Develop and monitor manufacturing Key Performance Indicators (KPIs). Prepare periodic operational reports for senior management. Analyze production data and recommend actions to improve overall factory performance.