Helping Medical Device and Regulated Manufacturers improve operational performance through expert consulting, workforce development, and execution-focused coaching.
NES provides specialized consulting services and training tailored to the unique needs of medical device and regulated manufacturing. We focus on enhancing efficiency, ensuring compliance, and fostering continuous improvement across your operations.
Customize tailored Knowledge Transfer strategies to achieve your organizational goals on critical projects like Design Transfers, Line Transfers, and Capacity Increases.
Reduce variation, standardize and minimize human error via a customized training on GMP/GDP, Data Analysis, FMEA management, and Technical Writing to ensure compliance and quality in medical device production.
Transform validation from a documentation exercise into a business advantage with expert coaching on risk-based approaches, best practices, execution excellence, and sustainable compliance.
Optimize your supply chain with our expert evaluation and risk assessment, ensuring reliable partnerships and robust performance.
Bridge language barriers with accurate, bilingual technical documentation, preventing costly errors and ensuring clear communication.
Empower your teams with the A3 methodology, a structured approach to identify, analyze, and resolve manufacturing challenges efficiently.
Develop teams capable of identifying and eliminating true root causes, reducing recurring issues and strengthening CAPA effectiveness.
Implement effective tiered meeting systems and instill shop floor discipline to drive daily performance and accountability.
Learn to identify hidden waste, optimize processes, and create faster, more efficient value streams that improve operational performance and business results.
Defining basic expectations for compliant performance
Customized training provided to engineering or operational teams on GMP/GDP, Data Analysis, FMEA Application, or any other area where basic principles are required to ensure success in performance while complying with industry standards.
Ensuring consistent quality and safety in production processes with special focus on risk and customer impact
Set your team for success with a customized training and follow-up strategy to ensure company's goals are achieved on projects like Design Transfer, Capacity Increase and Line Transfers.
Learn to understand data before it is used on decision making processes to ensure successful data-risked assed results
Go over basic expectation on how to use FEMA documentation to support decision making processes across different industry applications
FORMAT: Training is customized to the organization's need with special focus on real case-scenarios for each application.
Transform validation from a compliance requirement into a strategic advantage through practical training, proven industry best practices, and expert coaching based on real-world execution experience.
Goal: Build a reliable, scalable, and low-risk supply chain that supports your growth and protects your operation.
Evaluate suppliers' ability to meet current and future demands.
Identify the best suppliers by analyzing technical capabilities, quality systems, and strategic fit.
Identify potential risks (quality, regulatory, logistical) before they become costly problems.
1-2 day site visits + 3-day reporting cycle.
Clear supplier scorecards, risk matrix, recommended actionable improvement plans, and go-forward recommendations.
Goal: Eliminate costly errors, misunderstandings, and compliance risks caused by inaccurate technical documentation in global operations
Accurate and operator friendly translation of manufacturing procedures, including process instructions and safety protocols.
Clear translations of quality control documentation, including inspection criteria and compliance standards.
Precise translation of material specifications, including part details and requirements.
Key Advantage: Translations performed by personnel with ample industry experience in technical terminology
Delivery: Based on word count and complexity. All translations reviewed by bilingual engineers.
Goal: Building a Strong Culture of Structured Problem Solving.
This four-step process provides a structured approach to problem solving, moving from definition to implementation and standardization.
Focused on A3 mentality and not the template
Real manufacturing examples from regulated environments
8 hours class, includes hands-on practice. Remote or in person. Can be combined with RCA Training.
Goal: Develop teams capable of identifying and eliminating true root causes, reducing recurring issues and strengthening CAPA effectiveness.
Clearly define the problem and narrow the scope - GEMBA combined
Evaluate theories based on facts and data
State of the process and where exactly the problem is taking place - GEMBA combined
Identify potential factors based on 6 M's analysis
On line or Classroom class. Two hrs per tool to explain and practice. Practical exercises with real examples from your operation. Customized with your CAPA training program
KEY OUTCOME:
Bring Discipline, Visibility, and Accountability to Your Shop Floor
Goal: Prepare your organization for an effective Tiered Meeting System that reduces daily firefighting, improves communication, and drives continuous improvement at all levels.
Design and implementation of Tier Level Meetings (Tier 1 to Tier 4)
Definition of meaningful KPIs and visual management boards
Structured problem escalation process
Leadership coaching for sustainable execution
Integration with A3 and RCA problem-solving tools
Format: 8 hr class (remote or classroom) to explain fundamentals of Tier Management, implementation process, value added to the organization, and review real case scenarios. Further consulting (separately) to assist the organization in the principles of implementation and guidance on KPI's
Objective: Equip participants with the knowledge and practical skills to map, analyze, and improve value streams, enabling them to identify improvement opportunities, eliminate waste, and drive measurable operational results.
Most organizations don't suffer from a lack of effort—they suffer from hidden waste, disconnected processes, and missed opportunities. Our Value Stream Mapping training and coaching equips leaders and teams with a proven methodology to visualize end-to-end workflows, identify bottlenecks, eliminate non-value-added activities, and accelerate business performance.
FORMAT: 8hr class to go over fundamentals, structure, application and exercises for participants to drive VSM activities.
Antonio Valadez is an Engineering professional with 30 years of experience in the Medical Devices Industry with different leadership roles delivering measurable results in process improvement, design transfer, and operational optimization within regulated environments. Recognized for leading complex projects, streamlining manufacturing processes, and driving cost-effective, scalable solutions. Demonstrated success in building high-performance teams, mentoring technical talent, and fostering a culture of continuous improvement. Specialized in regulated environments and passionate about helping organizations implement practical, scalable solutions.
Contact Info: [email protected] | +1 650-464-5663
Antonio Valadez
Nexcellence Engineering Solutions (NES)
Email: [email protected]
Phone: +1 650-464-5663
Nexcellence Engineering Solutions (NES)