Quality Management Systems Consultant


Demonstrated project management and leadership skill-sets, and coordinated teamwork strategies in conceptualization, strategic planning, transformation, delivering and implementation of solutions for the organizational, operational and production projects in quality and regulatory management, process and production control, supply chain and supplier management, risk management, and change management through integrating business, engineering and management initiatives and principles; implement industry best practices; drive consistency and process harmonization; deploy continuous improvement concepts and lean manufacturing strategies for electro-mechanical and class I through class III medical devices.

  • Strategic planning and managing product, operational and facilities transfers, realignment and consolidation; seamless transition of new products into production with documentation, tools and fixtures, training, validation, calibration and preventative maintenance plan.  
  • Lead and support manufacturing operational management by driving process (gap analysis, development of methods, documentations meeting regulatory standards, guidance and practices – ISO and cGMP) and resource (space, manpower, equipment and measurement) identification, standardization, optimization, harmonization through process flow analysis and value stream mapping (VSM). 
  • Qualification and validation of facilities and production equipment, process, tool and fixtures by authoring protocols (master validation plan; installation, operational and process qualification), execution and generate reports collaborating with vendors, cross-functional team and subject matter experts (SME).
  • Perform quality audits and gap analysis (design, equipment, processes, material, regulatory and compliance requirements) of end-to-end supply chain, internal and external supplier. Provide advice and support through training, documentation, sampling plans, cost, scheduling and validation as needed.
  • Audit, review, investigate and analyze facilities and production, quality and supply chain non-conformances process against global standards (ISO and ANSI), good manufacturing practices (cGMP), supplier process and quality system (APQP and PPAP), quality management system (QMS), FDA and global quality system regulatory (QSR) requirements (FDA 21 CFR part 820, QSIT, FDA 21 CFR part 11, UDI – 21 CFR 801.45, ISO 15415, MDSAP, ISO 13485:2016 and 2019, ISO 14971, Medical Device Directive (MDD) and Medical Device Regulation (MDR)) through user and SME interview and Gemba walks, gap assessment, organizational effectiveness analysis, critical thinking, complex problem-solving application, root cause analysis, corrective and preventative actions (CAPA) by collaborating with cross-functional team and the leadership. 
  • Create and review risk management (user, design and process FMEA) and hazard analysis (HACCP) documents per design history file (DHF), device master record (DMR), operational processes and procedures, customer complaints, deviations and potential issues per device history record (DHR) to comply with all regulatory and quality management system.
  • Managing, implementing and supporting new business initiatives (UDI – unique device identification, CTO – configure to order, TPS – Toyota production system, zero and lean inventory, cleaning and disinfection studies of reusable device for clinical trial study)

Experience and knowledge of Project Management (APICS), Quality Management Systems (QMS), Business Process Improvement (BPI), Lean and Transformational strategies, Microsoft Office suite (Word, Excel, PowerPoint, Visio, Project and Outlook), AutoCAD and SolidWorks, Supplier Quality, Facilities Management, Risk Management, FDA and Global regulatory and compliance – QSR, MDSAP, EU MDD and EU MDR, UDI, ISO and ANSI standards.



  • Courses toward Master’s in Manufacturing Systems Engineering - Manufacturing Processes, Excellence in Operations, Statistical Methods for Manufacturing Quality, Managerial Accounting, Performance Management, and Leadership


  • Bachelor (Senior Certificate) in Business Administration through evening program

  • Bachelor of Mechanical Engineering with emphasis in Industrial and Systems Engineering

Additional courses and certification:

  • APICS - Supply Chain Management, Planning and Scheduling, and Project Management

  • Kepner Tregoe - Business Process Improvement (BPI)

  • University of Minnesota - Engineering Management, Human Factors Engineering, and Project Management.


Quality Management Systems Consultant                                                October 2020 – December 2020

Sanofi Biologics, Framingham MA

  • Review and investigate deviations for non-conformance, conduct root cause analysis (RCA), create CAPA action plans and suggested solutions for implementation and effectiveness.

Quality Systems and Risk Management Consultant                                                     July 2019 – February 2020

Sanofi Genzyme Biosurgery, Framingham MA 

  • Reviewed and assessed operational risk management (User, design and process FMEA - Failure Mode and Effect Analysis, HACCP - Hazard Analysis and Critical Control Points, Contamination Control, Environmental Monitoring and Facilities support system) procedures to meet the QMS, ISO and EU-MDR regulatory and compliance requirements.

  • Reviewed process (Batch Record, Bill of Material, Validation, Methods) and quality (certificate of compliance, deviation, incident report, complaints) document, and performed process and procedural gap analysis, and recommended corrective actions to meet the (ISO 14644 and EU Annex 1) compliance and regulatory requirements, for class III aseptic and implantable products through detailed process mapping, review of batch production records and standard operating procedures.

  • Analyzed complaints, deviations, root cause analysis (RCA), quality and change control data, and prepared Product Risk reports

  • Analysis of contamination sample data for Environmental Qualification and site selection.

  • Studied auto fill machine (Isolator) structure and operation in collaboration with facilities and operations. Designed sequence of events, Ishikawa diagram, and process flow and value stream mapping.

Operational and Risk Management Consultant                                                                    May 2019 -May 2019

Ventana Medical Systems (Roche Diagnostics), Tucson, AZ 

  • Conducted Gemba walk, equipment and process review, process, and value stream mapping of semi-auto fill reagent equipment for process gaps and operational (OEE) studies (run time, downtime, wait time, reject rate, and break down).

  • Reviewed documentations (operational, quality, risk, qualification, and training) and provided gap assessment with changes and updates as required.

  • In collaboration with internal SMEs, conducted pFMEA sessions to review and update the risk management documentation.

Quality Systems and Change Management Consultant                                 February 2017 – December 2018

Philips Healthcare, Bothell, WA

  • Performed assessment of current level of compliance against quality management system, global regulations, documentation system and training. Identified over 300 non-compliances in cGMP, CAPA, Root Cause Analysis (RCA), Quality Management System, supply chain, supplier quality documentation, incoming inspection processes and interfacing facilities equipment.

  • Conducted gap analysis and assessment by reviewing organizational and work structure, work instructions and standard operating procedures, drawings, FMEAs and product specifications by conducting Gemba walks, user interviews, review parts and product handling, storage, humidity and temperature requirements, process analysis and value stream mapping.

  • Reviewed and corrected deficiencies in process documentation, quality management systems, regulatory compliance, supplier quality, facilities equipment and services, calibration, and preventative maintenance.

  • Collaborated with internal and external cross-functional teams by providing subject matter expertise in problem solving and business process improvement (PDCA and DMAIC) for the best practices in supply chain and supplier quality management.

  • Authored, collaborated, reviewed and updated facilities, warehouse and receiving inspection processes, cleaning and decontamination of customer returned units, qualification and validation of facility systems (facilities master validation plan for compressed dry air, pest management, HVAC system, power quality management, building and contamination controls, and lighting). Validated the compresses dry air system and pest management program.

  • Prepared service level agreements with internal and external facilities service supplier with detailed statement of work including preventative and regular maintenance intervals

  • Assisted leadership team during all phases of regulatory audits, and in formulating responses in meeting the warning letter and consent decree requirements.

  • Conducted medical literature and regulation (MDSAP, MDR and Risk Management) searches, reviews and shared knowledge with leadership and team on impacts of changes (existing and upcoming) with gap assessment.

Manufacturing and Project Engineering Consultant                                                   May 2016 – January 2017           INTEGRA LIFE SCIENCES, Austin, TX

  • Instrumental in developing, planning, managing, and implementing Unique Device Identification (UDI) project roadmap, specification, and documentation (Validation Plans, Process Mapping, Validation Protocols, Inspection Plan, Process and Equipment training)

  • Developed plans and procedures for accessing gaps in capabilities of internal operational and supply chain, and sub-contracted manufacturer supplier base

  • Designed experiment guidelines and requirements to determine impact of different passivation methods, and multiple applications of decontamination, cleaning and sterilization process on UDI directly marked parts and on product’s life cycle        

  • Provided input and recommendations to corporate and site UDI project and management team in equipment selection and procurement, and process design for external supplier qualification

  • Troubleshoot issues and investigate solution for UDI laser marking, passivation, cleaning, and verification failures through benchmarking and collaborating with vendor and suppliers

  • Audited the supplier and assisted in equipment and process change request in qualification, sampling plan and cost impact studies. Provided supplier with MVP, IQ, OQ and PQ protocols.

  • Selected third party external supplier for cleaning and sterilization of UDI marked parts for DOE study through exhausting process in simulating the condition that parts may endure during its entire life cycle. Negotiated the entire project cost and cycle time.

  • Generated process flow for acquired systems through data and information gathering from contract manufacturer and multi-site cross-functional team.

  • Authored Performance Qualification protocol and reports for replacement of equipment, with contract manufacturer, engineering, and supply chain.

  • Created pFMEA and risk analysis for new foot and ankle implant devices through review of documents and clinical data.


Manufacturing and Project Engineering Consultant                                                      February 2016 – April 2016


  • Supported New Generation Products (NGP) change management by reviewing, engineering changes and updates to drawing / documents in collaboration with new product engineering, remote site manufacturing operations, document control, quality, and supply chain.

  • Generated process mapping, conducted time studies, capacity planning and improvement plans for decontamination, cleaning and transferring information from clinical studies of implantable device with marketing and design engineering.

  • Conducted CAPA studies and root cause analysis (RCA) for product failure / malfunction and possible change requirements for improvement with Product Reliability by studying the documents - PFMEA, DHF, DHR and FDA MDR (Medical Device Reporting).

Manufacturing and Project Engineering Consultant                                              October 2015 – November 2015


  • Conceptualized, developed, and designed lean packaging solutions and layout for transitioning UDI label equipment into pack line through assessment, constraints, requirements, process and capacity analysis, specifications, work and material flow, storage, and delivery methods.

  • Conducted feasibility studies for transitioning and integrating product by developing project plans and schedules for volume production by reviewing specifications / drawings and built structure for manufacturability, prototype and pilot builds, and creation of bill of material

  • Performed operational risk (D/PFMEA) management activities and gap analysis; Planned, scheduled and follow-up project timelines and progress of transition and launch

  • Coordinated procurement of capital equipment and tooling / fixtures with internal and external sources to meet capacity and capability requirements, established and scheduled calibration and preventive maintenance program with metrology and calibration provider for newly design surgical equipment for R&D engineering.

  • Authored cGMP operating procedures, work instructions, preventive maintenance, equipment qualification and validation (IQ, OQ and PQ) and process verification (PV) protocol. Execute IQ, OQ and PQ ensuring work conducted according to approved protocol.

  • Evaluated, aligned, and optimized resource (man, machine, method and material) for capacity, efficiency, capability, and utilization. Planned and design production requirements from value stream mapping, production baselines, 5S and yield management information.

  • Collaborate with operational team in arranging clean room for product launch and sustenance, conduct operator training, develop KPI matrix for production and quality data measurement.  

Manufacturing and Project Engineering Consultant                                                        February 2015 - July 2015


Manufacturing and Project Engineering Consultant                                            September 2014 - December 2014

DePUY SYNTHES (Johnson and Johnson), Monument, CO

  • Reviewed, updated, and approved IQ, OQ and PQ for equipment and tools for preparation for FDA audits and updated Design History Records (DHR) and Design History File (DHF).

  • Reviewed, updated, and completed Corrective Action and Preventive Action (CAPA) of identified gaps and deficiencies of fastening system for implantable orthopedic devices.

  • Performed IQ and OQ of UDI marking on parts through laser marking, passivation, and cleaning

Manufacturing and Project Engineering Consultant                                               June 2014 - September 2014


  • Conceived, investigated, designed and implemented by leading continuous improvements (Quality, Cost, Performance, Utilization and Delivery) and waste elimination (D.O.W.N.T.I.M.E) activities to drive operational and organizational performance improvement through lean, six sigma and supply chain transformation - culture, principles and practices.

  • Identified issues related to production system improvement. Planned and performed labor, CNC machine utilization (OEE) and capacity studies of implantable knee, hips and shoulder system. Presented findings to operations and stakeholders for change management.

Industrial and Project Engineering Consultant                                              February 2014 - June 2014


  • Troubleshoot manufacturing processes and equipment by planning appropriate corrective and preventative actions, developed maintenance plans, provided product line management (PLM) and engineering support through ERP change management systems for DHF remediation

  • Performed value stream and operational studies to redesign quality, packaging and warehouse processes and layout. Identified and procured equipment and fixtures for implementation

  • Conducted and participated in kaizen events with operations and management in designing improved documentation, layout, and processes (contract manufacturing of fastening systems for medical device)

  • Performed review of operating room tool design documents, and stack tolerance analysis.

Senior Industrial Engineer and Packaging Engineer                                                               2012 - 2013


  • Removal of 40% NVA cost in Packaging operation through lean studies, capacity improvement and resource (manpower, material, space, and equipment) optimization and utilization (OEE, 5S)

  • Led cross functional project team with key stakeholders in evaluating and streamlining process with 60% improvement in product quality through value stream, root cause and error proofing of Aluminum based heat transfer and cooling products for automotive, trucking and heavy duty off the road and agricultural machinery

  • Conceptualized and developed packaging strategies in effective procurement, lean inventory, and costing model, resolved packaging concerns by addressing processes and documentation (Bill of material and routing in AS400, and work instructions to meet TS16949 quality standards)

  • Identified, analyzed, and implemented plant-wide improvement projects in ergonomics, material handling and workflow, manufacturing equipment and processes collaborating with operations, engineering, quality, and supply chain.

Industrial Engineering and Manufacturing Engineering Consultant                                               2010 - 2012

FUJIFILM DIMATIX, Lebanon, NH; MENTOR TEXAS (Johnson and Johnson), Irving, TX; BELL HELICOPTER, Amarillo, TX; CATERPILLAR, Seguin, TX; and NJ & ASSOCIATES, Flower Mound, TX

  • Provided vision and conceptual operations and warehouse layout for anticipated 30% - 50% growth in next 5 years utilizing industrial engineering, lean principles and supply chain studies, mapping operational efficiency and continuous improvement process (Value Stream Mapping, 5S, Demand Flow Technology and zero inventory) to maintain operations in current location.

  • Reduced process errors through 5S, Lean Manufacturing and DMAIC process implementation

  • Established baseline measurements by evaluating sequence of operations, work measurement, time studies, process and material flow, value stream mapping and analysis

  • Performed gap analysis and suggested improvement opportunities (ergonomics, bottlenecks, work balancing, equipment utilization and automation), workstations and work areas layout.

  • Identified daily production constraints and limitations, and provided appropriate solutions

  • Supported engineering initiatives in transferring technologies and setup fool proof production system at Texas Power System for Caterpillar diesel Engine products

Senior Manufacturing Engineer                                                                              2007 - 2009


  • Actively supported multi shift operation in designing operational needs in capacity, capability, training, engineering changes, problem, and issues resolution in meeting KPI goal of 99%, on-time product delivery and yield.

  • Doubled production capacity and reduced cycle time in half by sequencing, balancing, single piece flow, material, and process flow improvements (DFT), and designing productive layout.  

  • Improved product yields 40% by addressing design, material, process, and supply chain issues.

  • Managed introduction of custom configured products through pilot builds, process validation, ISO 9000 documentations, tools, packaging, and yield management. Support and address issues with sustaining engineering, marketing, and project management throughout product lifecycle.

  • Designed and developed rework process resulting in recovery of 100k from material scrap plus minimizing production stoppage, meeting on-time delivery schedule and reducing expediting cost from overseas supply chain in Just in Time and Demand Flow environment of no inventory.

Senior Manufacturing Engineer                                                                            2005 - 2007


  • Increased production capacity and productivity by 60% through redesigning business process identified during Value Stream Mapping, by implementing Demand Flow Technology (DFT), Supply Chain initiative and Lean Manufacturing strategies.

  • Established lean manufacturing culture through work standardization, line balancing, design of workstations and production centers, removal of non-value-added tasks and streamlining material handling / flow, reduction in work in process inventory (zero), setup and wait time resulting in avoidance of acquiring new facility and relocation during 30% growth period

  • Instrumental in developing / setup corporate / facilities safety / ergonomics standards and programs to reduce accidents / health claims and perform internal audits

Engineering and Management Consultant                                                                         2002 - 2004


  • Provided technical analysis and subject matter expertise by recommending / implementing engineering and plant management solution.

  • Established key performance metrics (cost, time, and capacity) to measure effectiveness and viability of project, and data collection methodologies.  

  • Recommended 20% workforce reduction to operations and plant management to streamline operation based on baseline measurements, process, and value stream mapping.

Principal Industrial and Manufacturing Engineer                                                               2000 - 2002


  • Mentor and lead three interns in analysis of clean room packaging material, consolidation, and recycling project by revising and updating corporate packaging standards and processes, resulted in packaging material inventory reduction, lower disposal cost and carbon footprint.

  • Supported clean room production of high value precision equipment to meet production and revenue goals. Retrofit products during life cycle working with engineering and operations.

  • Evaluated and recommended ergonomics and safety improvements, process, and material flow improvements of multiple 300mm new product design /pre-production reviews resulted in production bay design modification, introduction of new tools and fixtures. Established baseline measurements for optimal performance and space utilization to plan and design productive operational layout for smooth 300mm product transition to Austin, TX from Santa Clara, CA.

  • Avoided multi-million dollars’ facilities retrofitting cost and shut down by standardizing multi-product use production bays and lean manufacturing process in configure to order equipment.

Engineering Support Services Manager                                                                                               1997 - 1999


  • Organized engineering and facilities department and managed eight cross-functional engineers and technicians, and two interns in product integration center to support 30% - 50% year over year business growth with continual introductions of new configured to order (CTO) products.

  • Identified, prioritized, and resolved barriers of team's performance by solving critical issues and effective decisions through leadership and people skills.

  • In nine months successfully reduced delivery and integration time by 30%, and improved inventory turnover by 33% by effectively managing product life cycle.

  • Increased customer satisfaction by reducing product damage 15% and packaging cost by 30% by redesigning packaging material and process.

Industrial and Manufacturing Engineering Consultant                                                                        1996 - 1997


  • Performed time studies of printed circuit board, component, and product assembly operation in establishing product cost in automotive and military electronics. Recommended changes to Bill of Material, operational sequencing, material and workflow, documentation, and layout.

  • Developed ISO packaging documentation of networking products from part drawings into standardized container with multiple inserts.


7 wastes of Lean Manufacturing (D.O.W.N.T.I.M.E), Total Quality Management Process (Juran), Just in Time and World Class Manufacturing (Richard Schonberger), Statistical Process Control (Deming) – Six Sigma, Toyota Production Systems, Demand Flow Techniques (DFT), Ergonomics, Safety (DuPont) program, Interpersonal and Communication Skills, Visual Management (Lockheed Martin), Organizational Development and Financial Accounting

Medical Devices – Change Management Process (CMP), Quality Management System (QMS), Master Validation Plans (MVP), Process Validation (PVP) and Qualifications (IQ, OQ and PQ), Corrective Actions and Preventive Actions (CAPA), Risk Management (DFMEA and PFMEA), FDA 21CFR-820, ISO13485:2003 and 2016, ISO14971:2007, Unique Device Identification (UDI), ISO 15415, GS1, ISO TR 29158, FDA 801.45. EU: Medical Devices Directives - MDD and Medical Devices Regulations - MDR

ERP Systems (Agile, Baan, Oracle, AS400, SAP and Ignite). 


INDUSTRIAL AND MANUFACTURING ENGINEERING - New Product Introduction, Strategic Business Planning, Validate Improvements, Engineering Change Orders, Problem Solving, Bill of Material, Operations and Facilities Planning and relocations, Capacity, Capability, Time Studies, Work Measurement, TAKT Time, Cycle Time, Productivity, Performance, Efficiency, Value Engineering, Work Design, Line Balancing, Material Flow, Process Flow, Workstations Design, Work Standardization, Space Planning, Manpower Planning, Material Handling and Storage Strategy, Documentation, Product Integration, Technology Transfer, Project Management, Sequence of Events, Statement of Work (SOW), Facilities consolidation, integration / rearrangement and layout, Manufacturing Execution System – MES

ENGINEERING MANAGEMENT – Project Planning and Execution, Process Owner, Managing Team – Coaching and Mentoring, Time Management, Performance / Salary Evaluation, Leadership, Budgets, Capital Equipment Planning / Procurement and Justification, ROI Analysis

LEAN AND AGILE MANUFACTURING - Value Stream Planning, Eliminate Operational Waste (value and non-value added tasks, D.O.W.N.T.I.M.E), Cellular Manufacturing, Pull System, Visual Workplace, Visual Management, One Piece Flow, Demand Flow, DFT, Just in Time (JIT), Kanban, Kaizen, Continuous Improvement Methodology, OEE, Gemba Walk, Management by walking, 4M, A3, 5S, 6S and 8D, Mistake proofing, SIPOC, Spaghetti Diagram, Standard Work

ERGONOMICS / HUMAN FACTORS ENGINEERING - Safety, OSHA, Job Analysis, Ergonomics, Injury and Risk prevention, Design – Process, tool, fixtures.

SUPPLY CHAIN MANAGEMENT – Source Planning, Customer Service, Risk analysis, Synchronization, Consignments, Warehousing, VMI (Vendor Managed Inventory), Qualification, Quality, AQPQ, PPAP

QUALITY AND SIX SIGMA - DMAIC, Statistical Process Control (SPC), Lean Six Sigma, Quality Management Systems (QMS), Qualification and Process Validation – IQ / OQ / PQ, FDA 21CFR 820, QSIT, 21 CFR part 11, Yield Improvement, Root Cause Analysis, ISO9001, ISO 13485:2003 and ISO 13485:2016, ISO 14971:2007, PPAP, TS16949, First Articles, Corrective and Preventive actions (CAPA), Control Charts, Pareto Diagram, DFMEA, PFMEA, re-mediation, ISO 15415, ISO TR 29158, GS1, UDI, FDA 801.45, MDSAP, MDR, MDD

REMEDIATION: Gap analysis, Quality Management System, Quality System Regulations, QSIT, Supplier Quality Management, Verification and Validation, CAPA, Process Controls, Documentation, 483, Warning Letters, Consent Decree, Risk Management, DFMEA, PFMEA, Global Regulatory Agencies and Regulations, cGMP, Project Management 

Submit the form below to express your interest in this professional.