Jeffery M. Smith

• Research & Development Project Management
• Serve as the Principal Investigator for 2 concurrent Phase 2 SBIR grant projects for the DoD, leading critical defense-related innovations
• Led feasibility studies to prioritize product development projects, enhancing ROI by over 30%
• Spearheaded the review and approval of design documents, ensuring compliance and innovation in designs
• Directed Root Cause/Risk Management initiatives, reducing project risks by identifying critical issues
• Successfully launched a new product through the EUA process, achieving market penetration within 6 months
• Managed a team of 5 Senior Engineers, overseeing 3 major projects simultaneously, under budget and on time
• Quality/Regulatory
• Spearheaded the review and approval of change orders and compliance documents including DMRs, DHRs, and corrective action reports, ensuring alignment with industry standards and enhancing product quality
• Directed comprehensive investigations into product complaints, leading to regulatory actions and recalls, significantly mitigating potential risks and maintaining compliance
• Actively participated in and provided expert insights during internal and external audits, contributing to continuous compliance and process enhancements
• Human Resources/Portfolio Management
• Conducted comprehensive annual performance reviews for direct reports, fostering professional development and enhancing team performance metrics
• Identified key organizational weaknesses through strategic analysis, developing and implementing targeted action plans that improved operational efficiency by 25%
• Crafted and negotiated critical agreements including surgeon consultant and distributor agreements, ensuring legal compliance and advantageous terms that enhanced business operations
• Led regular stakeholder meetings to evaluate progress on strategic initiatives, enhancing project alignment and stakeholder engagement
• Managed the processing and analysis of financial and operational data using MS Excel and QuickBooks, ensuring exacting standards of quality assurance and control
• Developed and delivered key reports and presentations that supported strategic company objectives and facilitated informed decision-making
• Provided critical support in data analysis, enhancing the accuracy and reliability of business insights
• Supervised and streamlined record management and archiving processes, guaranteeing data integrity and access compliance
• Delivered comprehensive financial reports and essential documentation to stakeholders, maintaining transparency and fostering trust
• Engaged actively with physicians, facility managers, and other key stakeholders to build and maintain strong professional relationships.
• Managed time efficiently in order to complete all tasks within deadlines.
• Assisted with day-to-day operations, working efficiently and productively with all team members.

• Managed budgets and financial forecasting to ensure fiscal responsibility and maintain profit margins.
• Facilitated regular leadership meetings to discuss progress on strategic goals, identify opportunities for improvement, and address challenges proactively.
• Spearheaded strategic planning initiatives for long-term growth and profitability.
• Boosted operational efficiency by streamlining processes and implementing cost-saving measures.
• Mentored employees at all levels within the organization to support their professional development goals.
• Influenced company culture by promoting core values like integrity, accountability, innovation, teamwork, and excellence throughout daily operations.
• Collaborated with cross-functional departments to optimize workflow and enhance communication channels.

• BK160045 Cyclone Platelet Rich Plasma Separator for Bone Graft Handling; BK170198 Platelet and Plasma Separator for Bone Graft Handling; K173128 Intervertebral Fusion Device with Bone Graft Handling; K201521 Appliance, Fixation, Spinal Intervertebral Body
• Sales
• Drove operational excellence strategies that escalated annual revenue from $12M to $50M
• Oversaw daily sales operations, tracking and analyzing monthly results to refine forecasting accuracy
• Established rigorous sales goals and metrics, and enhanced sales team skills through targeted "lunch and learn" training programs
• Negotiated contract pricing and successfully resolved escalated customer issues, enhancing client satisfaction and retention
• Led key strategic meetings and professional conferences, fostering team alignment and advancing organizational goals
• Supervised and ensured the thorough processing and auditing of applications and reappointment paperwork, maintaining high accuracy standards
• Conducted qualitative analyses to verify data accuracy and consistency, significantly reducing data discrepancies
• Coordinated the integration of credentialing data across multiple software platforms, streamlining administrative processes
• Acted as a key secondary contact for credentialing issues, ensuring efficient resolution and communication
• Supervised credentialing operations, managing critical files and addressing issues promptly to uphold compliance standards
• Marketing
• Supervised internal and external marketing teams, facilitating seamless communication between marketing and product development departments to align strategies
• Designed and approved a range of marketing materials, including brochures, pamphlets, trade show booths, and websites, ensuring brand consistency and appeal
• Planned and led trade show strategies, supervising booth setups and engaging in product line discussions to enhance product visibility and networking
• Directed branding decisions, ensuring consistency and coherence across all product lines to maintain brand integrity and market recognition
• Accounting
• Directed all accounts receivable and payable activities, overseeing general bookkeeping functions including balance sheets, profit & loss statements, and public ledgers to ensure financial accuracy and compliance
• Developed and implemented comprehensive customer service programs, introducing metrics and policies that significantly enhanced order fulfillment processes and operational efficiency
• Prepared the annual budget using advanced forecasting methods, continuously monitoring and adjusting to align with financial goals and organizational growth
• Created and managed a robust purchase order system, overseeing all orders for stock replenishment and project-specific purchases to streamline production and testing phases
• Research & Development
• Coordinated feasibility studies to strategically select product development projects, focusing on maximizing ROI and minimizing development timelines
• Reviewed and approved all design documents, including detailed engineering plans, drawings, and test reports, ensuring adherence to technical specifications and quality standards
• Engaged in and led Root Cause and Risk Management activities, addressing project challenges, complaints, and non-conformances to enhance product reliability and compliance
• Facilitated the successful market release of seven product families, managing the ongoing support and enhancement of multiple product lines to ensure market competitiveness
• Supervised Project Managers and Engineering staff, effectively coordinating up to six concurrent projects to ensure timely delivery and adherence to project scopes
• Quality/Regulatory
• Conducted thorough reviews and approvals of all change orders, nonconforming material reports, DMRs, DHRs, corrective actions, and supplier management records, ensuring stringent compliance with regulatory standards
• Directed the investigation and resolution of product complaints, culminating in necessary regulatory notifications and recalls, reinforcing safety and quality protocols
• Contributed expertise in numerous internal and external audits, enhancing compliance procedures and organizational practices through proactive involvement
• Led the initiative for ISO certification, orchestrating a series of process evaluations and improvements that fortified compliance and enhanced quality assurance measures across the organization
• Human Resources/Portfolio Management
• Executed annual performance evaluations, providing feedback and development paths for direct reports, fostering professional growth and performance improvements
• Systematically identified and addressed organizational inefficiencies, implementing targeted action plans to strengthen operational effectiveness
• Drafted and finalized key agreements including surgeon consultant and distributor agreements, as well as various contractual documents, optimizing organizational legal standing and operational logistics
• Facilitated regular stakeholder meetings to transparently communicate project statuses and strategic developments, enhancing stakeholder engagement and alignment
• Managed comprehensive data processing tasks, including data entry, analysis, quality control, and integration using MS Excel and QuickBooks, ensuring high standards of data integrity and usability
• Developed and delivered strategic reports and presentations that supported organizational objectives and informed strategic decision-making
• Provided pivotal support in ad-hoc data analysis, delivering critical insights that informed business strategies and operations
• Crafted and submitted detailed reports and presentations to company executives, adhering to strict deadlines to support timely and effective executive decisions
• Conducted detailed data reviews to ensure utmost accuracy and compliance with regulatory standards, maintaining the organization’s data integrity
• Oversaw and managed record management and archiving processes, ensuring systematic documentation and compliance with legal requirements
• Delivered essential financial reports and customer service documentation to external stakeholders, upholding transparency and fostering trust
• Engaged actively with a diverse group of stakeholders, including physicians and facility managers, to foster relationships and facilitate collaborative initiatives
• Supported space management strategies, enhancing operational efficiency through optimized space utilization and the implementation of effective space standards.

• K133321 Intervertebral Fusion Device with Bone Graft, Cervical; K140303 Intervertebral Fusion Device with Bone Graft, Lumbar; K141993 Appliance, Fixation, Spinal Intervertebral Body; K141123 Plate, Cranioplasty, Preformed, Alterable Complaint Handling
• Wrote and established policy to receive, investigate, determine the root cause, determine disposition and report complaints (when necessary) resulting from sub-optimal product results
• Average closure rate of fewer than 30 days
• Reviewed and approved all complaint files, including proprietary products and distributed product lines
• Interfaced with field employees, contractors, facilities, and end-user customers to collect data regarding product performance
• Corrective Action Preventive Action
• Participate in the implementation of the CAPA software solutions program
• Monitor information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of timelines, and establishing CAPA files
• Serve as a resident point of contact in CAPA regulatory/compliance
• Monitor the effectiveness of the CAPA system
• Coordinate all needed training for users of the CAPA system
• Serve as the coordinator of the CAPA meetings
• Trend CAPA metrics and present defined reports at specified intervals
• Current CAPA information during Management Reviews
• Maintain and revise applicable procedures as necessary
• Assist/Interface with CAPA owners on CAPA Investigations and Action Plans
• Perform various activities for the regulatory compliance department, including support of the internal audit program and document control
• Conduct training on CAPA tool usage
• Familiar with good Manufacturing Practices and QSR/ISO regulations
• Familiar with modern quality control/assurance techniques such as corrective/preventative action plans and root cause investigations
• Supplier Management
• Wrote and established policy to manage the company Approved Vendor List (AVL)
• Established inspection criteria for all products received (proprietary and distributed) through the creation of device specification sheets
• Conduct quarterly supplier review meetings with stakeholders to add or remove suppliers from the AVL based on the accuracy of delivery and on-time rate
• Conducted external supplier audits at supplier facilities as needed based on risk level Employee Training
• Plan annual training for all employees
• Design and develop training programs (outsourced and in-house)
• Select appropriate training methods or activities
• Market available training to employees and provide necessary information about sessions
• Conduct organization-wide training needs assessment and identify skills or knowledge gaps that need to be addressed
• Use known education principles and stay up-to-date on new training methods and techniques
• Design, prepare and order educational aids and materials
• Assess instructional effectiveness and determine the impact of training on employee skills and KPIs
• Gather feedback from trainers and trainees after each academic session
• Partner with internal stakeholders and liaise with experts regarding instructional design
• Maintain updated training matrix and training records
• Host train-the-trainer sessions for internal subject matter experts
• Manage and maintain in-house training facilities and equipment
• Research and recommend new training methods as needed
• Controlled Documents/Change Orders
• Establish a policy to keep all controlled documents for the company
• Select and validate a software system to manage the QMS
• Responsible for maintaining all design history files for completed projects, device master records detailing the manufacturing processes of those products, and device history files of all received products upon release
• Process all standard and engineering change orders (open to close was an average of 4 days) Internal Audits
• Performed and controlled the entire audit cycle, including risk management and control management over operational effectiveness, financial reliability, and compliance with all policies and regulations
• Determine internal audit scope and develop annual plans
• Obtain, analyze and evaluate documentation, previous reports, data, flowcharts, etc
• Prepare and present information that reflects the audit's results and document process
• Act as an objective source of independent advice to ensure validity, legality, and goal achievement
• Identify loopholes and recommend risk aversion measures and cost savings
• Maintain open communication with ownership
• Document process and prepare audit findings memorandum
• Conduct follow up audits to monitor interventions
• Engage in continuous knowledge development regarding sector's rules, regulations, best practices, tools, techniques, and performance standards
• Support Product Development/Project Management/Program Management/Portfolio Management
• Wrote and established policy to systematically control and move design projects through a regulatory compliant design control project to gain regulatory approval
• Participate in and approve design control documentation resulting from design phase reviews throughout the course of product development from design initiation through market release
• Conduct quarterly post-market surveillance meetings and produce detailed reports of regulatory actions for proprietary and competitive products to identify issues before they occur proactively
• Instrumental in the release of Four (4) medical device "families" through the FDA approval process
• Conduct a risk assessment of product family before release and work with R&D to mitigate those risks
• Inventory Management
• Implemented and managed an inventory management system (5000+ products) that included sales orders, transfer orders, packing, shipping, receiving, and issuing RMA's as needed
• Established and managed the budget for third-party shipping and receiving vendors (FedEx, UPS, USPS, etc.)
• Managed product storage in an environmentally controlled method to ensure a high-quality product is delivered to the end user, including PEEK, titanium, injection-molded, and donated tissue products per regulatory guidelines
• Support the full range of logistical support to include assisting in ordering equipment, supplies, being accountable for equipment and receipts and supplies, equipment accountability
• Maintain spreadsheet for tracking all medical device systems, expenditures, and other information
• Support with communications travel support, printing, library or publication services, mail, facilities, and equipment, transportation, records, forms, and reports
• Responsible for coordinating assigned tasks to ensure smooth operation, proper delivery of products, and adequate customer support
• General logistic management operations involve planning, coordinating, or evaluating the logistical actions required to support a Joint traumas system mission
• Maintain or supervise the calendar of key events and activities related to the activities
• Plan, organize and execute travel and files vouchers for team members
• Responsible for all Computer Support Services to include initial troubleshooting for the company

• Developed and enhanced the complaint management system, reducing resolution times by 40% and increasing customer satisfaction
• Re-engineered the lot numbering system to improve product identification and traceability, enhancing supply chain efficiency
• Streamlined sterile packaging processes to exceed FDA compliance requirements, ensuring a 100% audit pass rate
• Implemented a controlled document system for standard operating procedures that improved regulatory compliance and operational efficiency
• POC for recertification audits for both ISO and FDA investigators
• Contributed to root cause analysis to determine core reason for failures and errors.
• Performed quality inspections and drafted reports to detail non-conforming material issues.
• Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
• Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
• Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department.
• Streamlined internal communication, fostering cross-functional collaboration between engineering, manufacturing, and quality teams.
• Conducted detailed audits to ensure adherence to ISO 9001 standards, maintaining a high level of compliance throughout the organization.

• Led failure investigations for medical devices, significantly reducing recurring issues and enhancing product reliability
• Compared and analyzed findings in existing QMS documentation to ensure failure modes were adequately documented
• Enhanced investigation efficiency by 75%, accelerating problem resolution and improving product safety metrics
• Achieved top performance in closing investigation files with the highest accuracy and compliance rates among peers.
• Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
• Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.

• Investigated and resolved over 60 customer complaints daily, enhancing customer trust and satisfaction through precise and timely resolutions
• Designed and delivered training programs for new hires, boosting department efficiency and knowledge retention.
• Worked well in a team setting, providing support and guidance.
• Self-motivated, with a strong sense of personal responsibility.
• Excellent communication skills, both verbal and written.
• Assisted with day-to-day operations, working efficiently and productively with all team members.
• Worked flexible hours across night, weekend, and holiday shifts.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Proven ability to learn quickly and adapt to new situations.
• Proved successful working within tight deadlines and a fast-paced environment.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Skilled at working independently and collaboratively in a team environment.
• Adaptable and proficient in learning new concepts quickly and efficiently.

• Spearheaded the development of rapid antigen detection using Pyrosequencing technology, significantly speeding up pathogen identification times.

• Material Analysis: Conduct chemical testing on polymers, fibers, and other materials used in seatbelts to ensure they meet safety standards and performance specifications.
  
• Quality Control: Implement and oversee quality control procedures, using analytical techniques such as chromatography, spectroscopy, and titration to monitor material consistency and identify any deviations.
  
• Failure Investigation: Investigate material failures, degradation, or chemical inconsistencies, analyzing root causes and providing recommendations for corrective action.
  
• Compliance Testing: Ensure that materials and products comply with regulatory standards, including automotive safety and environmental regulations.
  
• Research and Development Support: Collaborate with the R&D team to develop new seatbelt materials or improve existing ones, ensuring they meet both safety and cost-effectiveness criteria.
  
• Reporting and Documentation: Maintain detailed reports of chemical tests, analyses, and investigations, ensuring accurate record-keeping for audits and regulatory inspections.

• K102956 Contributed to the R&D of V.A.C
• Granufoam Silver Dressings, improving product efficacy and patient recovery rates in clinical settings
• Project: K103156 Contributed to the development of the K103156 V.A.C
• Veraflo Cleanse Dressing System, playing a key role in integrating advanced cleansing solutions with vacuum-assisted closure therapy to enhance patient recovery outcomes.

• Team Leadership: Supervise, train, and motivate store staff, including pharmacists, pharmacy technicians, and sales associates, ensuring high performance and customer satisfaction.
  
• Sales and Profitability: Drive sales growth by developing strategies to meet or exceed revenue targets, managing expenses, and implementing promotional campaigns.
  
• Inventory Management: Ensure optimal stock levels, including pharmacy products and general merchandise, by managing inventory orders, monitoring stock rotation, and addressing supply chain issues.
  
• Customer Service: Maintain a high standard of customer care, handling complaints, resolving issues, and ensuring that both retail and pharmacy services meet customer needs.
  
• Compliance and Security: Ensure compliance with all legal, health, and safety regulations, including those specific to the pharmaceutical industry, while securing store assets and overseeing loss prevention.
  
• Financial Management: Oversee budgeting, cash handling, and financial reporting to ensure the store operates within financial guidelines and meets profitability goals.

• Staff Leadership: Recruit, train, and manage store employees, ensuring high performance and adherence to company policies. Conduct regular performance reviews and provide coaching to enhance team effectiveness.
  
• Sales & Revenue Growth: Develop and implement strategies to meet and exceed sales goals, maximizing revenue through product rentals, sales, and customer retention initiatives.
  
• Customer Service: Ensure customers receive excellent service, addressing complaints and resolving issues promptly to maintain customer satisfaction and loyalty.
  
• Inventory & Asset Management: Manage inventory levels, ensuring products are well-stocked, organized, and displayed. Oversee product delivery, collection, and asset recovery to minimize losses and improve efficiency.
  
• Financial Management: Oversee store budgeting, cash handling, and expense management. Ensure accurate financial reporting and adherence to company policies.
  
• Compliance: Ensure the store complies with Rent-A-Center policies and procedures, as well as local and federal regulations, including health and safety standards.
  
• Marketing & Promotions: Implement in-store marketing campaigns and promotions to drive customer traffic and increase sales.

Supervised correctional officers and inmates, ensuring safety, security, and compliance with institutional policies and state regulations. Key responsibilities include:

• Supervision and Leadership: Direct and oversee the work of correctional officers, ensuring that they maintain proper inmate control and adhere to policies and procedures.
• Security Enforcement: Monitor and enforce security protocols, perform routine inspections, and ensure the safety of staff, inmates, and the facility.
• Incident Response: Lead the response to emergencies, disturbances, and rule violations, documenting incidents and taking corrective action when necessary.
• Inmate Management: Oversee inmate movement, behavior, and compliance with rules. Facilitate rehabilitation and provide guidance to correctional officers on inmate supervision.
• Training and Development: Provide training, mentorship, and performance evaluations for correctional staff, ensuring that they meet TDCJ standards.
  Administrative Duties: Prepare reports, maintain records, and ensure proper documentation of security operations and incidents.