Senior Operations Manager chez EKF Diagnostics Inc

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.

Essential Functions, included but not limited to:

• 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.

Other Functions:

• 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.

Supervisory Responsibilities:

• 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.

Travel:

• None.

Requirements

Required Qualifications:

• 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 out-of-specification (OS) investigations.
• In-depth knowledge of various standards and regulations such as ISO 9001, ISO 13485, the Quality System Regulation (21 CFR Part 820).
• Experience in a cGMP or regulated environment.
• Experience with Enterprise Resource Planning (ERP), Warehouse Management System (WMS), or other inventory management systems.
• Knowledge of local, state, and federal environmental, health, and safety compliance laws and regulations.

Preferred Qualifications:

• Bachelor's degree required or equivalent combination of experience and education.
• Laboratory experience in a biology, chemistry, or medical environment.
• Knowledge of biological and/or chemical concepts.
• Previous experience in a supply chain role or working in or with logistics.
• Experience in purchasing within a manufacturing setting.
• Understanding of inventory numbering and product identification processes.
• Experience with assembly line machinery.
• Forklift certified or able to become forklift certified.
• Basic Skills and Abilities:
• Strong computer skills including Microsoft Word, Excel, Outlook.
• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Proven ability to manage multiple projects and meet deadlines; work in a fast-paced environment.
• Excellent organizational skills to meet goals and set priorities.
• Initiative to offer new innovative ideas and improve processes.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Ability to work independently and as a member of various teams and committees.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Demonstrated ability to analyze and interpret information.
• Foster a participative management style advocating a team concept.
• Good coaching, mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.

Reasoning Abilities:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. 
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 
• Language Skills:
• Good written and oral communication skills; ability to read, write, speak, and understand the English language.
• Exceptional interpersonal and leadership skills; ability to communicate effectively, internally, and externally at all levels and diverse personalities.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
• Ability to write reports, business correspondence, and procedure manuals.
• Mathematical Skills:
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents

Visual Acuity:

• Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

Physical Demands:

• Must be able to wear and work in personnel protective equipment (PPE) as required; full coveralls required in cleanroom.
• Physical activity performing strenuous daily activities in a production, manufacturing, and warehouse setting.
• Frequently move about the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
• Frequently stand for prolonged periods of time.
• Occasionally sitting for a period of time for data entry.
• Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
• Frequently lift and carry up to 50 pounds with no assistance; occasionally carry, push, pull or otherwise move objects up to 100 pounds with assistance.
• The ability to hear, understand, and distinguish speech.
• Frequently communicate information and ideas so others understand. Able to exchange accurate information in these situations.
• Occasionally reaching for items above and below desk level.
• Occasionally required to climb or balance; squat, stoop, kneel, crouch or smell.

Environment Conditions:

• Well lit, heated/air-conditioned indoor office/production setting with adequate ventilation.
• Cleanroom is a cool, window-less, confined space environment.
• Noise level in the work environment is moderate.
• Frequent exposure to low temperatures in controlled refrigerators and/or freezers. 
• Frequent exposure to biohazards, fumes, and other airborne particles.
• Occasionally exposed to high and low temperature and outdoor elements such as precipitation and wind.
• Potential exposure to biohazards, fumes, and other airborne particles.