Senior Operations Manager

Description Summary of Position

Directs operations across multiple departments involved in the manufacturing and distribution of clinical diagnostic testing products. This includes:

• Production:
  Overseeing packaging, kit assembly, and device creation.
• Manufacturing:
  Managing the production of reagents and kit assembly.
• Logistics:
  Handling purchasing, shipping, receiving, and warehousing.

• Responsible for the overall management and strategic oversight of the Operations division at the Boerne site.
• Strategically plan and schedule production operations, establishing the sequence and priority of manufacturing activities to optimize output and workflow.
• Review raw materials and MRP (Material Requirements Planning) activities to ensure the production and quality of all products align with established specifications.
• Direct operations departments, aligning their processes with overall organizational goals. This involves overseeing equipment maintenance, assessing training needs, and developing infrastructure to economically improve performance.
• Drive the development of staff and direct reports through strong leadership and mentorship.
• Analyze production orders and schedules to ascertain product specifications, quantities, and deadlines, and plan department operations accordingly;
  Advise Head of the Americas if the schedule cannot be met.
• Manage all activities to meet and maintain compliance with relevant national and international standards and regulations, such as the FDA, ISO, and MDSAP.
• Review operating reports to proactively address and solve operational, manufacturing, and maintenance challenges, thereby reducing costs and avoiding delays.
• Collaborate with Compliance and Customer Service to determine Operation requirements.
• Conduct regular inspections of machines and equipment to maximize operational performance and utilized at their maximum capacity.
• Ensure all machine maintenance records are meticulously reviewed and maintained in full compliance with the Quality Management System (QMS).
• Develop and update Standard Operating Procedures (SOPs), Packing Instructions (PIs), Work Instructions, and other technical documents. Conduct regular observations to verify compliance and identify opportunities for process improvement.
• Analyze customer order requirements and existing plans to optimize processes to consistently meet or exceed customer expectations.
• Responsible for creating, tracking, and reporting on the department's key performance indicators (KPIs) and statistics. This includes conducting a thorough root cause analysis when performance targets are not met and implementing effective corrective actions.
• Drive continuous improvement in production and operational processes, focusing on enhancing quality, lowering costs, and boosting overall effectiveness.
• Identify and communicate quality concerns with urgency; issue nonconformance report (NCR), TDNs, CAPAs, etc. as needed.
• Drive strategic supply chain planning by working with Sales, focusing on timely procurement and delivery to optimize efficiency and guarantee on‑time customer orders.
• Maintain an efficient supply chain to ensure product availability for both manufacturing and sales as determined by the ERP system and management.
• Partner with the Quality Control Laboratory to ensure timely completion of all required reagent testing based on company demands and priorities.
• Implement and uphold quality management guidelines.
• Monitor training and performance records for all assigned personnel.
• Assist the logistics team in conducting accurate and timely monthly, semi‑annual, and annual inventory counts.
• Adhere to current Good Manufacturing Practices (cGMP);
  Ensure all direct reports comply.
• Comply with Company policies, Quality Management System (QMS), and Standard Operation Procedure (SOPs), etc.

• Ensure compliance with safety regulations and procedures are followed;
  Maintain clean and safe work area.
• Assist as needed in other areas of the Company where training requirements have been completed.
• Perform other duties as assigned.

• Directly manage the Manufacturing & Production Manager and Logistics Manager at the Boerne site.
• Fulfill manager responsibilities in accordance with the organization's policies and applicable laws;
  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• None.

• High School Diploma or its equivalent.
• Legally authorized to work in the United States.
• Extensive leadership experience within the medical technology industry.
• Three (3) or more years of proven experience in direct supervision or management .
• Direct experience with in‑vitro diagnostic.
• Proven experience in the manufacturing of medical devices.
• Experience in change management, root cause analysis, risk assessment, and…