Director of Quality Operations

Job Overview The Director of Quality Operations is responsible for overseeing the company's Quality Management System (QMS), regulatory quality activities, outsourced manufacturing relationships, supply chain, inventory, and business operations. The company utilizes third-party contract manufacturers for the production of its medical devices. Accordingly, this position focuses on ensuring that external manufacturing partners and suppliers meet established quality, performance, and regulatory requirements while maintaining effective internal operational processes. The Director of Quality Operations provides leadership across quality assurance, supplier management, procurement, inventory management, product acceptance, distribution, service operations, facilities, and administrative functions. The position is accountable for establishing and maintaining compliant, efficient, and scalable processes that support product quality, customer satisfaction, regulatory compliance, operational efficiency, and the company's business objectives. Duties Quality Management System (QMS): Direct the development, implementation, maintenance, and continuous improvement of the company's QMS in accordance with applicable FDA regulations, ISO 13485, and other relevant quality standards. Audits and Management Reviews: Plan and coordinate internal, supplier, customer, certification, and regulatory audits; manage audit findings and corrective actions; and conduct periodic QMS management reviews. Contract Manufacturer and Supplier Management: Oversee qualification, approval, performance monitoring, quality agreements, and compliance of third-party contract manufacturers and critical suppliers. Product Quality and Configuration Management: Ensure appropriate oversight of product specifications, design changes, manufacturing changes, software revisions, product configurations, labeling, and traceability. Inventory and Logistics Management: Oversee inventory control, warehousing, receiving, shipping, distribution, stock management, and maintenance of accurate inventory and product traceability records. Customer Complaints and Product Reliability: Coordinate the investigation and resolution of product complaints, technical issues, service trends, and recurring failures in collaboration with engineering, suppliers, and customer support. Business and Administrative Operations: Direct designated day-to-day business operations, including facilities, equipment, administrative services, vendor contracts, operational purchasing, and internal controls. Financial and Resource Management: Support operational budgeting, expenditure management, resource allocation, cost optimization, and planning to ensure efficient utilization of company resources. Business Continuity and Operational Risk: Identify and manage operational risks associated with suppliers, inventory, infrastructure, service delivery, and business continuity. Process Improvement and Operational Excellence: Lead initiatives to standardize workflows, improve organizational efficiency, reduce costs, strengthen regulatory compliance, and enhance product quality and customer satisfaction. Personnel Management and Development: Supervise assigned quality and operations personnel, establish performance expectations, oversee training and competency programs, conduct evaluations, and support hiring and professional development. Experience Quality assurance experience within healthcare and project management experience in healthcare; demonstrated team leadership. Knowledge of applicable FDA & ISO regulations, accreditation standards, and healthcare compliance. Experience with procurement, inventory management, supply chain, and operational processes. Strong project management, process improvement, and risk management skills; technical proficiency with Microsoft Office. Knowledge of medical law, health regulation policy, and electronic health records management. Pay: $80,000.00 - $100,000.00 per year Benefits: 401(k)…

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