CLIFFORD LONG
Des Moines Iowa Area | - |-| www.linkedin.com/in/clifflong
STATISTICIAN
Business Transformation Leader | Trainer | Problem Solver
Focused on improving consistency, quality, reliability, and compliance
Industrial Process | Product Design | Quality Systems and Metrics | Business Forecasting | Data and Text Mining
Accredited Professional Statistician (PStat) with record of accomplishment in manufacturing quality, product design and reliability, operations analytics, regulatory compliance, and Six Sigma.
Application specialties: business management and quality & process improvement for industries including Medical Devices, Aerospace and Defense, Chemical and Material Processing, Consumer Goods, Pharmaceutical, and Distribution.
Success leading cross-functional and cross-facility teams and liaising with stakeholders, ensuring collaborative and sound decision making that balances compliance and product performance.
As a Subject Matter Expert, developed and conducted trainings on statistical methods that solve problems for national and international quality and reliability engineers, scientists, manufacturers, developers, Six Sigma Black Belts, and Data Analysts.
PROFESSIONAL EXPERIENCE
ARGON MEDICAL DEVICES, Wheeling, ILNovember 2021 to Present
Manager of Quality and Compliance
Support the development and validation of test methods and measurement systems and the ongoing monitoring of manufacturing processes to ensure stability, capability, optimization, and robustness. Introduce statistical design of experiments (DOE) into process validation activities incorporating logistic regression, survival analysis, model diagnostics, and verification.
Use R statistical programming environment to create applications that automate the analysis of qualification data, providing improved knowledge of Voice of the Process (VOP) in less time.
Participate in post-launch reviews and multifunctional evaluation and investigate product/process performance. Monitor and communicate trends in attrition and performance through thought papers and presentations, including changes, strengths, or weaknesses derived through statistical findings.
Project Highlights:
After nonconforming product was discovered at supplier’s Incoming QC Inspection, developed a GR&R study comparing two of Argon’s measurement systems with one system from supplier.
Identified one unreliable Argon measurement system, prompting corrective action to use fixturing for the parts.
To address excessive scrap generated during injection molding process, with "length" as the primary issue, conducted a repeated measures study suggesting an upstream process as the root cause, followed by a multi-gauge GR&R study.
Revealed upstream measurement system error up to 130% of the part tolerance, justifying capital investment in a more capable system.
In response to increased need for time-intensive qualification of newly introduced products and processes, built applications using R statistical software platform to automate common analyses for process validation, mold qualification, and incoming inspection.
Reduced time spent on analysis and report writing from hours to minutes, shifting work from Engineers to QC inspectors.
To reduce confusion caused by variations in facility metrics generated by multiple departments and facilities, built Power BI applications fed with data from the enterprise resource planning (ERP) system. ETL process included SQL and DAX.
Enabled weekly monitoring of data designed to facilitate multi-level Pareto analysis, resulting in timely alerts and actions based on standardized data and resulting metrics.
EFFECTIVE STATISTICS, INC., McHenry, ILApril 2014 to Present
Owner, Principal, and Consultant
Provide statistical consulting services, training, and mentorship to companies ranging from small organizations to Fortune 500 companies in industries including medical device (ISO 13485), aerospace and Dept. of Defense (AS9100), semiconductor, industrial, and oil and gas (ISO 9001). Client projects included:
Convatec (global medical products): Assessed test methods, including intra-facility and inter-facility evaluations. Provided logistic regression with Odds Ratios and model diagnostics augmented by survival analysis to explore relationships between visual assessment and quantitative measures of pressure decay. Designed and analyzed study combining stochastic FEA with DOE to evaluate performance contributors for ostomy system.
Avery Dennison/Vancive (medical adhesive solutions): Designed and performed test method validation modified from ISO 22196 for evaluating antimicrobial properties of a new film for three organism types.
Rayovac (battery manufacturer): Used Mixed Effects model to determine baseline variability of pilot line-produced cells, as well as the contribution to variability from electrolyte batch/day, component set, and build-day.
Dentsply Sirona (dental products): Utilized survival analysis models to develop reliability estimates based on service and complaint data for their catalog of products. Included recurrent events analysis with mean cumulative function, survival plot, and hazard function.
DEXTER MAGNETIC TECHNOLOGIES, Elk Grove Village, ILAugust 2018 to July 2021
Director of Quality and Compliance
Led global quality and regulatory function of an aggressively growing business serving the medical device, aerospace, DOD, semiconductor, industrial, and oil and gas industries. Oversaw numerous successful BSI surveillance and recertification audits across three quality system standards (ISO 9001, AS9100, and ISO 13485).
Improved the effectiveness and reduced the execution time of design and process validation activities through improved statistically designed experiments.
Developed statistical model for test method validations to apply Measurement System Analysis (MSA / GR&R) to magnetic mapping systems with complex geometries and response variables for medical device applications.
Devised statistical method for modeling magnetic output and variation of advanced magnetic assemblies for aerospace/ DOD applications.
Standardized data for Business and Quality System metrics by collaborating with Operations and Finance to create a query allowing a reproducible data extraction for a system of analytics for weekly monitoring.
The standardized data enabled more frequent and reliable trending and allowed focused improvement efforts, leading to quicker success with verifiable results.
ESSENDANT (f/k/a United Stationers), Deerfield, ILApril 2014 to August 2018
Director of Supply Chain Quality
Provided leadership and instruction of statistical methods to improve and monitor operations performance across 70 national wholesale distribution, warehousing, and fulfillment facilities in three business units. Introduced data science methods, including web-based statistical dashboard and automated alert system for key metrics.
Provided automated monitoring of distribution center metrics with a statistical process control system using R and Shiny, including SQL, on a Linux server. Generated alerts and escalations based on statistically relevant signals (excursions and trends) and provided web interface for real-time performance tracking.
To combat pilferage, applied data science methods to screen and provide automated alerts across thousands of items and dozens of facilities.
The resulting early detection process included daily proactive monitoring for statistically relevant signals, reducing the time spent identifying and correcting issues from months to days.
ACCO BRANDS CORPORATION, Lake Zurich, ILApril 2012 to January 2014
Director of Quality Engineering
Tasked with recreating a lapsed quality system across corporate headquarters, established global integration of quality systems and standardization of practices and metrics using quality engineering methods.
Implemented training program on Quality Engineering/Six Sigma statistical methods related to qualification of product designs and manufacturing processes.
Trained initial team of six Quality Engineers in Asia to improve supplier outcomes, using ASQ CQE Body of Knowledge. This resulted in dozens of studies uncovering and resolving poor manufacturing processes and measurement systems.
To address high rates of misclassification when monitoring returns data for 4,600+ SKUs, developed a system of automated SPC monitoring (built using Statistica, MS Access/SQL, and Visual Basic), allowing monthly filtering for significant events or trends and enabling a system of prioritization including both statistical and financial metrics.
HOLLISTER INCORPORATED, Libertyville, IL2001 to 2012
Senior Manager, Quality Engineering -)
Developed team of quality engineers recognized by all global facilities as center of excellence for quality and reliability engineering. Incorporated advanced quantitative methods to provide solutions for robust processes, fewer defects, less waste, decreased redundancy, and improved consistency and regulatory compliance.
Initiated multi-stage DOE approach, using Resolution III and Resolution V designs, to assist Ireland engineers in tackling stalled project: creation of a production-ready process for urinary catheter coating requiring dozens of sequential steps. After applying the principle of hierarchy of effects, with verification runs post-DOE, project moved forward to product launch.
Worked with engineers at India plant developing a sealing process for sterile packaging of medical devices, who were facing challenges providing consistent output.
Implemented a statistically designed experiment combining factorial DOE with logistic regression based on a pass/fail test of a sample of units. The process was set within a window where no regular amount of variation of process inputs would create a bad seal, if properly maintained.
Developed program of Measurement Uncertainty Budgets and nonstandard MSA methods, providing solutions for measurement challenges in product design and manufacturing processes.
Developed SAS Macro enabling distribution fitting for censored data.
Manager, Quality Engineering -)
Developed training program for non-Quality Engineers (design and development scientists and engineers, and manufacturing engineers) on the design of statistical studies and the application of statistical methods.
Included DOE, Statistical Process Control and Process Capability, and MSA.
Training content became the backbone of personal website, www.statrefs.net.
BELTONE ELECTRONICS, Chicago, IL 1995 to 2000
Director, Quality and Regulatory Affairs -); Director, Product Services -);
Service Manager -); Manufacturing Training Coordinator -); Production Supervisor -)
Managed four departments with 50+ employees, including managers and supervisors. Maintained medical device standards and regulations, representing quality system through two FDA inspections without any 483 Findings, and several successful ISO audits.
ADDITIONAL EXPERIENCE
DEPAUL UNIVERSITY, Chicago, IL, Adjunct Professor. Served as instructor of Applied Statistics in graduate statistics program, and instructor of Data Science for graduate accounting program. Three courses developed and taught using SAS and R.
UNITED STATES MARINE CORPS, Enlisted Infantryman, Infantry Officer, & Staff Officer. Provided leadership at platoon, company, and battalion levels during several deployments and operations. Planned and executed training of Marines and Marine leaders featuring units of up to 400.
EDUCATION
M.S., APPLIED STATISTICS, DePaul University, Chicago, IL 2006
M.B.A., Lake Forest Graduate School of Management, Lake Forest, IL 2001
B.S., ELECTRICAL ENGINEERING, Iowa State University, Ames, IA 1987
CERTIFICATIONS AND PROFESSIONAL DEVELOPMENT
Certified Quality Engineer, ASQ (#42851)
Certified Reliability Engineer, ASQ (#5276)
Certified Quality Auditor, ASQ (#28489)
ASA Accredited Professional Statistician™ (PStat®)
Lead Auditor (ISO 13485:2016, ISO 9001:2015, AS9100D)
Lean Six Sigma Green Belt (IISE)
TECHNICAL SKILLS
MS Office Suite, R (including data science, ML packages), Statistica, SAS, Minitab, IBM SPSS, SharePoint, SQL, GitHub, Microsoft Power BI, Linux, AWS
SAS experience and coursework includes: graduate program student coursework; graduate program SAS instructor; SAS Programming Essentials; SAS Data Literacy Essentials; SAS Certification Review; development and use of SAS macros.
STATISTICAL SKILLS
ANOVA
Design of Experiments
DOE with Reliability, Logistic Regression models
General/Generalized Linear Models
Lot Acceptance Sampling (attributes, variables data)
Machine learning methods (supervised, unsupervised)
Measurement System Analysis (GR&R, Fleiss Kappa)
Non-parametric methods
Power analysis
Predictive modeling, Dimension reduction, Classification
Resampling, Bootstrapping, Simulation
Statistical Process Control (univariate, multivariate)
Survival/Reliability Analysis (Non-parametric, Parametric)
Time Series Methods
