Vice President/General Manager in Boerne, Texas at EKF DIAGNOSTICS INC

SUMMARY OF POSITION:

The Vice President/General Manager is the senior on site leader responsible for the operational and strategic management of EKF Diagnostics’ Boerne, Texas manufacturing facility. This role requires strong ownership, visibility, and cross functional leadership while balancing strategic oversight with daily operational execution.

ESSENTIAL FUNCTIONS, included but not limited to:

• Provide clear direction, vision, and leadership of Boerne site operations fostering a culture of safety, quality, and operational excellence.
• Oversee facility operations, space utilization, security, and readiness to support compliant manufacturing and business continuity.
• Provide hands-on strategic and operational leadership across manufacturing, production, facilities/maintenance, supply chain, customer service/support, and human resources to ensure safe, efficient, compliant, and cost-effective operations.
• Ensures the facility delivers high quality products, and operates with efficiency by establishing a culture, accountability, teamwork, and continuous improvement.
• Ensure efficient and reliable execution of manufacturing and related operations to meet production schedules, service levels, and business commitments.
• Drive continuous improvement efforts using Lean, Six Sigma, or other methodologies to improve efficiency, reduce waste, and increase capacity.
• structure, performance, and productivity.
• Drive disciplined production planning and cross-functional coordination to support changing customer demand, new product introductions, and supply chain variability.
• Ensure adequate maintenance and readiness of equipment, tools, and facility infrastructure.
• Champion a safe workplace and ensure compliance with applicable environmental, health, and safety (EHS) requirements.
• Lead site emergency preparedness and business continuity planning efforts.
• Develop and execute long-term strategic goals for the Boerne site in alignment with EKF Group strategy.
• Support growth of the site’s Contract Manufacturing Organization (CMO) business and external customer partnerships.
• Ensure strong collaboration with EKF global leadership and other manufacturing sites.
• Serve as the primary site decision-maker for operational priorities, resource allocation, escalation management, and issue resolution.
• Partner with executive leadership to support long-term business growth, operational scalability, and organizational capability development.
• Translate corporate goals into actionable site-level KPIs; Implement site KPIs such as throughput, on-time delivery, scrap, rework, labor productivity, inventory performance, and cost control to enhance
• Partner closely with Quality leadership to maintain compliance with requirements such as FDA Quality System Regulation (21 CFR Part 820), ISO 13485, GMP, and other applicable regulatory or customer standards.
• Champion a quality first mindset across the site; promote a strong quality culture emphasizing product integrity, documentation accuracy, traceability, risk management, and audit readiness.
• Support internal audits, external audits, supplier audits, customer audits, and regulatory inspections as the senior site leader.
• Ensure timely and effective response to nonconformances, CAPAs, deviations, complaints, and systemic quality issues impacting site performance.
• Make operational financial decisions regarding the site profit and loss (P&L), including budgeting, capital expenditure (CapEx) planning, and cost-reduction initiatives.
• Drive operational performance to meet delivery, cost, and profitability targets.
• Contribute to sustainable site growth and long-term competitiveness.
• Collaborate with corporate leadership on long term planning, product launches, and strategic investments.
• Lead, coach, develop, and retain a high performing team across all levels of the organization.
• Partner with Human Resources on performance management, employee relations, organizational development, workforce planning, employee retention initiatives, and policy compliance.
• Ensure clear communication of business priorities, operational expectations, and organizational changes across the site including regular updates, town halls, and team engagement activities.
• Coordinate site execution in partnership with the following functions through dotted-line reporting: Quality Assurance, Quality Control, Regulatory Affairs, Finance, and IT.
• Adhere to current Good Manufacturing Practices(cGMP).
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

OTHER FUNCTIONS:

• Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
• Support additional company initiatives as required.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Directly site personnel across multiple functions such as manufacturing, production, customer service, technical support, human resources and logistics; indirectly manage personnel within compliance, finance and IT.
• 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 in partnership with HR.

TRAVEL:

• 15%; Occasional travel to South Bend, IN.

REQUIRED QUALIFICATIONS:

• Legally authorized to work in the United States.
• Bachelor’s degree in Engineering, Operations Management, Life Sciences, Business, or a related field
• Minimum 7 years of experience in site management or senior operations leadership within regulated manufacturing (medical devices, diagnostics, biotech).
• Demonstrated success in a regulated quality environment with direct exposure to FDA, ISO 13485, GMP, MDSAP and/or similar standards.
• Experience with Lean manufacturing, performance optimization, change management, and continuous improvement initiatives.
• Strong business acumen with the ability to manage budgets, staffing, productivity, and cost performance.

PREFERRED QUALIFICATIONS:

• Master’s Degree in Engineering, Business Administration, Life Sciences, or related field.
• Prior experience leading or significantly supporting a small to mid-sized manufacturing site.
• Experience in Point-of-Care consumables manufacturing.
• Background in Contract Manufacturing (CMO)/customer-facing manufacturing operations.
• Certification in Lean Manufacturing or Six Sigma (Green/Black Belt).
• International leadership experience within a global matrix organization.
• Strong proficiency in ERP systems and production planning software.
• Experience serving as the senior leader of a standalone manufacturing or operations site.

BASIC SKILLS AND ABILITIES:

• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple priorities and meet deadlines; work in a fast-paced environment.
• Detail-oriented with strong accountability and ownership mindset.
• Strong analytical, problem-solving, decision-making, and risk-assessment capabilities.
• Capacity to foster a participative management style advocating a team concept.
• Ability to lead through influence and build trust.
• Excellent mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.
• Proficiency with ERP/MRP systems, production metrics, and standard business software tools.
• Good computer skills including Microsoft Word, Excel, Outlook.

REASONING ABILITIES:

• Strong ability to interpret business, technical, and financial information.
• 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:

• Excellent written and verbal communication and interpersonal skills with the ability to influence at all levels of the organization.
• Ability to read, write, speak, and understand the English language.
• 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.
• Physical activity performing strenuous daily activities in a production setting.
• Constant repetitive motions that may include the wrists, hands and/or fingers to fill, assemble, label, or pack product and operate keyboard and mouse.
• Dexterity and coordination are necessary to handle small components and electronics.
• Ability to hear, understand, and distinguish speech.
• Often stand for prolonged periods of time; Occasionally sitting for periods of time.
• Frequently lift, carry, push, pull or otherwise move objects up to 50 pounds without assistance; occasionally carry, push, pull or otherwise move objects over 50 pounds with assistance.
• Often reaching for items above and below desk level.
• Occasionally climbing ladder, squatting, stooping, kneeling, or crouching.
• Occasionally move about the facility to access office machinery, correspond with other departments, attend meetings/training, etc.

ENVIRONMENTAL CONDITIONS:

• Well lit, heated/air-conditioned indoor production setting with adequate ventilation.
• The noise level in the work environment is moderate.
• Occasional exposure to low temperatures in controlled refrigerators and/or freezers.
• Potential exposure to biohazards, fumes, and other airborne particles.