Senior Operations Manager

Job Description

• This position is 100% onsite!
• No Relocation Assistance Available.

Summary :

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.

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.

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.