Director of Operations

About Us: Purity One, a subsidiary of Flow Control Group, manufactures custom single-use and hose solutions for the global life sciences, biotech, and pharmaceutical industries. Our products are manufactured in a certified ISO Class 7 cleanroom with a formal Quality Management System that is ISO 13485 certified. What sets Purity One™ apart is our expert-driven specification and commitment to quality. Our highly responsive operations and supplier agnostic approach allow us to manufacture solutions to meet the unique requirements of our customers’ manufacturing processes with unmatched speed and accuracy. Visit our Website: purityone.com Job Description: Responsibilities Lead cleanroom and hose assembly operations, including production planning, scheduling, capacity, labor utilization, workflow, productivity, and on-time delivery. Translate customer demand and business priorities into realistic production plans, balancing capacity, materials, labor, quality, and delivery commitments. Maintain a visible presence on the production floor; identify constraints, resolve issues, and drive accountability for safety, quality, delivery, productivity, and cost. Ensure operating processes, documentation, traceability, and cleanroom practices support the site's ISO 13485 Quality Management System and customer requirements. Supply Chain, Inventory & ERP Lead supply chain activities covering purchasing, material availability, inventory planning, and coordination with production. Maintain accurate control of raw materials and finished goods, including lot traceability, expiration dates, inventory accuracy, and material disposition. Use the ERP system as a core operating tool for production planning, material requirements, scheduling, inventory planning, costing, and performance reporting. Improve the connection between demand, purchasing, inventory, production capacity, and customer delivery while balancing service, working capital, and expiration risk. Lean, Daily Management & Continuous Improvement Implement and sustain Lean practices, standard work, and Tiered Daily Management to create a disciplined operating rhythm and clear accountability. Establish meaningful KPIs for safety, quality, delivery, productivity, inventory, and cost; use them to identify problems, escalate issues, and drive structured root-cause problem solving. Lead measurable improvements in throughput, lead time, labor efficiency, inventory, quality, and customer delivery. Cross-Functional & People Leadership Partner closely with Quality to resolve process issues, nonconformances, and corrective actions while maintaining production continuity and compliance with ISO 13485 requirements. Work effectively with Sales, Customer Service, Engineering, and Quality to establish realistic commitments and reliable execution. Build a culture of ownership, teamwork, safety, quality, continuous improvement, and customer focus while developing frontline leadership capability and operational talent. Qualifications Bachelor's degree in Engineering, Operations, Supply Chain, Manufacturing, Life Sciences, or a related field preferred. 7–10+ years of progressive manufacturing, operations, supply chain, or plant leadership experience, preferably in a small or mid-sized manufacturing environment. Demonstrated leadership of assembly manufacturing with responsibility for production performance, scheduling, capacity, labor, and delivery. Strong supply chain experience, including materials planning, purchasing, inventory management, lot control, expiration management, and production planning. Demonstrated experience using ERP systems for production planning, material requirements, inventory management, costing, and operational reporting. Practical experience with Lean manufacturing, continuous improvement, standard work, visual management, and/or Tiered Daily Management. Experience in a regulated, quality-sensitive, cleanroom, medical, pharmaceutical, biotech, life sciences, or s…

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