Operations Specialist II

The Operations Specialist II is responsible for executing and maintaining operational processes, including inventory control, logistics, traceability, purchasing activities, and light facilities management, in compliance with the company’s Quality Management System (QMS) and applicable regulatory requirements, including 21 CFR Part 820 and ISO 13485. This role ensures complete and accurate product traceability, supports procurement, inventory control, logistics activities (kitting, shipping, receiving), and maintains documentation required for audit readiness and regulatory compliance. The position also supports the efficient operation of office and facility environments through coordination of vendors, supplies, and facility-related services. Key Responsibilities Execute operational, purchasing, and facilities-related activities in accordance with approved procedures, work instructions, and controlled documentation. Maintain complete and accurate Device History Records (DHR) and associated documentation to ensure traceability and compliance. Ensure end-to‑end product traceability, including lot/batch tracking of materials, components, and finished goods within ERP/QMS systems. Perform purchasing activities and supplier coordination. Support supplier management activities and approved supplier records. Collaborate with Quality, Operations, and Finance teams. Perform kitting activities and maintain traceability documentation. Execute shipping and receiving processes, including incoming inspection and documentation. Record all transactions to ensure data integrity. Monitor inventory levels and support demand planning. Maintain alignment between physical inventory and system records. Adhere to document control requirements. Support internal and external audits. Participate in CAPA processes and continuous improvement activities. Identify and raise nonconformances and quality concerns. Support training activities and documented competency requirements. Coordinate facility‑related services and vendors. Monitor office, kitchen, and facility supplies. Track maintenance requests and repairs. Assist with workspace organization and onboarding setup. Maintain facility‑related records and vendor contacts. Support workplace health and safety initiatives. Collaborate with service providers to support business continuity. Qualifications Bachelor’s degree in Business, Operations, Supply Chain, Life Sciences, or related field (or equivalent experience). 3–6+ years of experience in operations, purchasing, logistics, procurement, or supply chain within a regulated environment. Demonstrated experience maintaining traceability records, DHRs, purchasing documentation, inventory records, and controlled records. Working knowledge of 21 CFR Part 820 and ISO 13485 requirements. Experience working within a Quality Management System (QMS) and supporting audits. Familiarity with supplier management, purchasing processes, lot/batch traceability, inventory control, and nonconformance processes. Experience with ERP/MRP and/or QMS systems. Experience managing purchase orders, inventory replenishment, and supplier communications preferred. Experience supporting office operations, facilities coordination, vendor management, or workplace services preferred. Key Skills Strict adherence to procedures and documentation requirements. Purchasing and supplier coordination. Product traceability and inventory control. Audit readiness and inspection support. Quality systems compliance (QMS, CAPA, document control). Attention to detail and data integrity. Problem‑solving and root cause identification. Cross‑functional communication in regulated environments. ERP/MRP system proficiency and procurement transaction management. Facilities coordination, vendor management, and office operations support. Regulated environment requiring strict compliance with documented procedures and quality standards. Requires accurate, timely documentation and record‑keeping. May involve physical handling of materials and inventory in office, laboratory, or controlled environments. Hybrid or in‑office depending on company needs; role includes coordination of operational activities, inventory management, logistics support, purchasing, and light facilities management responsibilities. #J-18808-Ljbffr