Supply Chain Director

The Supply Chain Director or Manager is responsible for developing, implementing, and optimizing Inquis Medical's end-to-end supply chain strategy to ensure the timely, cost-effective, and compliant delivery of materials, components, and finished medical devices. This role manages procurement, inventory planning, supplier relationships, contract manufacturing coordination, logistics, and supply chain risk management while ensuring compliance with FDA, ISO 13485, and other applicable regulatory requirements. This is a hands‑on position that will partner closely with Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, Finance, and external suppliers to support product development, commercialization, and ongoing manufacturing operations. Major Duties and Responsibilities Develop and execute supply chain strategies that support company growth, product launches, and operational objectives. Establish supply planning, inventory management, and forecasting processes to support production and commercialization needs. Monitor supply chain performance metrics and implement continuous improvement initiatives. Lead Sales, Inventory, and Operations Planning (S&OP) activities where applicable. Source and qualify suppliers, contract manufacturers, and service providers. Negotiate pricing, contracts, quality agreements, and supply agreements. Establish strategic partnerships with key suppliers to ensure continuity of supply. Evaluate supplier performance through quality, delivery, cost, and responsiveness metrics. Conduct supplier business reviews and support supplier audits in partnership with Quality. Manage inventory levels to balance supply continuity with cost efficiency. Develop inventory policies for raw materials, components, and finished goods. Monitor inventory accuracy and implement controls to reduce excess and obsolete inventory. Coordinate material planning to support production schedules and clinical activities. Collaborate with contract manufacturers and internal stakeholders to ensure production schedules are met. Manage purchase orders, production forecasts, and demand planning activities. Support new product introductions by ensuring material readiness and supplier capacity. Coordinate supply chain activities for clinical builds, pilot production, and commercial manufacturing. Oversee domestic and international shipping, warehousing, and distribution activities. Ensure timely and compliant movement of products and materials. Develop contingency plans to mitigate transportation and logistics disruptions. Monitor freight costs and optimize distribution networks. Ensure supply chain activities comply with FDA Quality System Regulation (QSR), ISO 13485, and applicable international standards. Partner with Quality Assurance on supplier qualification, audits, corrective actions, and quality agreements. Maintain documentation required for supplier management and regulatory inspections. Support internal and external audits as needed. Identify and mitigate supply chain risks, including single‑source suppliers and component shortages. Develop business continuity and supplier contingency plans. Monitor global market conditions and proactively address potential disruptions. Lead and mentor supply chain personnel as the organization grows. Partner with Finance to support budgeting, cost reduction initiatives, and inventory reporting. Collaborate with Engineering and Product Development to support design transfer and supplier selection. Provide supply chain insights and recommendations to executive leadership. Other duties as assigned. Education Requirements Bachelor's degree in Supply Chain Management, Business, Operations Management, Engineering, or related field required. MBA or advanced degree preferred. APICS/ASCM certification (CPIM, CSCP) or equivalent preferred. Experience Requirements Minimum 7–15 years of progressive supply chain, procurement, or operations experience. Minimum 3 years of leadership experience preferred. Experience within the medical device, life sciences, biotechnology, or regulated healthcare industry required. Experience supporting product development through commercialization strongly preferred. Experience managing contract manufacturers and global suppliers preferred. Required Skills / Abilities Strong knowledge of medical device supply chain and manufacturing processes. Understanding of FDA regulations, ISO 13485, supplier controls, and quality systems. Expertise in procurement, demand planning, inventory management, and logistics. Strong contract negotiation and supplier management skills. Experience with ERP/MRP systems and supply chain analytics. Excellent project management and organizational skills. Strong analytical and financial acumen. Ability to thrive in a fast‑paced startup environment and manage multiple priorities. Excellent communication and relationship‑building skills. #J-18808-Ljbffr