Quality Assurance Philosophies, Techniques

PUBLIO MORERA

** ******* ******

Palm Harbor, Florida 34683

(C) 727-***-****

Email: *******@**.*** LinkedIn http://www.linkedin.com/pub/publio-morera/12/868/342

PROFILE

A dynamic Quality Assurance Management Professional with solid defect prevention, issue resolution and regulatory compliance experience. Expertise in combining solutions in cost reduction, quality/performance and project management to increase profits through process improvements. Bilingual (English/Spanish)

PERFORMANCE QUALIFICATIONS

Quality Assurance Philosophies, Techniques & Principles

Six Sigma, Kaizen, Lean Teams, 5S and TQM techniques deployment and application.

Provide and evaluate statistical data concerning product, process, and components.

Measure efficiency and performance directly impacting product quality.

Achieve process quality improvement by analyzing and defining product and process criteria,

Address issues of preventative maintenance, line parameters, process and product re design and modifications.

Evaluate production issues; resolve through appropriate supplier channels.

Administer calibration programs.

Create/revise documents and forms relating to Quality Assurance issues.

Oversee quality function in new equipment purchase, validation, verification, process capability, line/product

trials and new component assembly

Product Standards, Troubleshooting, & Customer Service

Establish product standards and ensure process consistency via statistical process controls.

Spearhead and coordinate ISO certification activities.

Provide issue resolutions and troubleshooting within rapid manufacturing environment.

Implement and maintain corrective actions, documentation and quality systems/functions.

New Product Development – quality systems.

Perform detailed failure analysis of electrical and electronic devices - generate corrective solutions.

Investigate and resolve customer complaints.

Coordinate/direct corrective action systems.

Interpret customer specifications to provide: quality systems, workmanship standards -review purchase orders for compliance (NADCAP); perform quality system surveys/audits;

Team Management & Communication

Drive Culture Shaping and Organizational Redesign activities.

Develop train and manage audit teams to ensure FDA, GMPs and ISO compliance.

Assemble and lead process improvement teams to resolve issues, improve/optimize existing functions.

Spearhead and develop cost saving initiatives /projects.

Lead and supervise quality and production personnel in matters of compliance and quality.

Manage quality of overseas production plants.

Create and administer training programs to educate personnel in Quality Assurance methods/systems for workmanship, specification, assembly instruction, etc.

Technical teaching/training and motivational speaking experience

Publio Morera

PROFESSIONAL HISTORY

Magnum Quality Management – Quality Consultant Palm Harbor, Florida 04/2011 – Present

Comprehensive quality assurance solutions incorporating results-oriented, Lean quality consulting, quality audits, Lean manuals and documentation, effective practical training, and more.

Audit and Analyze systems from top to bottom and design innovative strategies to eliminate problems.

Maximize productivity, mitigate risk improve bottom line results by affecting processes, people, culture, customer focus, and operational performance.

Transform corporate cultures to achieve quality objectives through coaching, training, motivational presentations, team building, and empowerment.

Demystify quality requirements, standards, and specifications, enabling organizations to add value through simplicity, increased efficiency and effectiveness, and reduced costs.

Bausch and Lomb - Complaint Investigator Clearwater, Florida Contract 02/2011- 04/2011

Manage the Customer Complaint Program to meet cGMP, ISO 9001, ISO 13485 regulatory requirements and B&L policy.

Present complaint data for management review.

Conduct investigations based on complaint severity and reportability requirement.

Analyze data to identify correlation between customer complaint incidence and manufacturing processes characteristics.

Communicate potential process improvement recommendations where appropriate.

Compile and analyze complaint results quarterly to identify complaint trends, types, products and frequency.

Technology Transfer Services Inc. - Technical Developer/Writer Tampa, Florida Contract 02/2010- 11/2010

Provide technical writings and drawing corrections to develop maintenance and operations manual for new equipment.

Produce procedural process documentation as related to all operations and maintenance for the specified equipment including electronic maintenance manual for bulk mail sorting system for Northrop, Grumman and US Postal Service.

Utilize software programs including SharePoint, Arbortext Editor, Astoria and Cadstar.

Adjust technical terminology as required.

Technology Research Corporation - Quality Engineer St. Petersburg, Florida Contract 02/2009- 04/2009

Develop and implement ISO 9001 processes.

Lead development of corrective actions.

Audit processes and products to promote compliance and continuous product and process enhancements.

Develop and implement plans to accomplish quality process improvements and cost reduction projects.

Manage and monitor CAPA system for continued effectiveness.

Accomplishment: Processed dozens of open corrective action items in record time including supporting corrective

action documentation ensuring final ISO audit lead to certification.

Honeywell - Product Quality Engineer Clearwater, Florida Contracts 10/2007-10/2008

Drive the culture change to a lean organization. 09/2004-01/2005

Provide sustaining support to the manufacture of circuit card and final assemblies.

Participate in Kaizen Events; long term Future State mapping and Organizational Redesign activities.

Support lean manufacturing transformation of the Integrated Product Teams (IPTs). Including cycle time, inventory

reduction, FPY and customer escapes.

Perform RCCA, purge and disposition activities for non-conforming product.

Create shop floor metrics for site level management and corporate leadership.

Supplier Quality Engineer Create quality plans, perform supplier audits, implement closed loop corrective actions, generate quality metrics & reports plan, design & deploy quality assurance initiatives with global supplier & contract manufacturers.

Verify process controls are executed as planned, work with suppliers to improve processes/quality utilizing LEAN concepts,

8D and 6 Sigma methodologies.

Accomplishment: Attacked endemic quality issues affecting multilayer interconnect boards (MIBs) - Eradicated

defects by assembling cross functional teams, proposing and driving creative solutions.

Jabil Circuit, Inc.- Consultant Product Quality Engineer St. Petersburg, Florida Contract 01/2006-10/2006

Provide Prototype to first production support including configuration management.

Product Validation and Testing of consumer electronics including Four Corners, Temperature, Humidity, Voltage Variations

and Thermal Shock.

Perform Mechanical Robustness, Packaged & Unpackaged, Drop, Mechanical Cycling, and User Interface Evaluations, developing test methods analyzing results.

Execute audits of design projects for compliance to the product creation process.

Facilitate the creation of manufacturing requirements manuals (MRM) from engineering team input.

Facilitate/participate DFMEAs.

Identify, correct and escalate issues related to product risk level, safety, quality, reliability, and customer satisfaction.

Review key metrics-supplier issues, manufacturing yields, fall-outs, component failures, on-going reliability test results,

field failures and customer complaints.

Accomplishments: Developed novel Configuration Management method, crucial product specification for sourced

esoteric test equipment as part of development of a new RPTV.

Publio Morera

PROFESSIONAL HISTORY cont’d.

Baxter- Senior Product Surveillance Associate Largo, Florida Contract 10/2005-12/2005

Lead process improvements / projects.

Initiate, coordinate and document complaint investigations and initiating CAPAs.

Identify and manage continuous improvement and education opportunities.

Conduct and document comprehensive quality reviews of closed investigations.

Execute high-risk/ in-depth complaint investigations.

Minimize the company’s exposure to liability, quality and regulatory risks.

Coordinate analysis, document investigation plans, compiling / filing regulatory documentation/convening/coordinating meetings.

Provide expertise in handling complaints, CAPAs and Medical Device reporting regulations.

Mercury Medical-Quality Assurance Engineer Clearwater, Florida Contract 03/2005-09/2005

Design/ implement policies / procedures in compliance with FDA, ISO, UL, OSHA, EPA, ASTM, and ANSI.

Recreate and maintain Design History files and other medical device protocols

Perform Root Cause Analysis. Investigate product failures and field complaints.

Execute Capability and Validation studies.

Conduct Risk Analysis, Validation and Verification activities related to medical devices.

Create and conduct training on quality control activities.

Develop policies and methods for testing/evaluating efficacy of products / equipment.

Conduct CAPA and risk management activities / research / evaluate product safety levels.

Accomplishment: Assured FDA compliance by eliminating a 4 year back log of medical device complaints performing discrete investigation of field medical personnel to asses report ability requirements and implement corrective action.

Estee Lauder – Quality Manufacturing Specialist Melville, New York 1996-2004

Introduce and train in Six Sigma, Kaizen, Lean Teams and TQM techniques to positively affect process outcome.

Create & administer training programs to educate production personnel in QA methods, gage system usage for specifications artwork, assembly instructions etc.

Assemble teams to resolve issues/improve/optimize existing functions and develop cost saving initiatives and projects.

Audit for GMPs, ISO, FDA, CAPA, compliance and address Safety/Health concerns of OTC drug manufacturing.

Accomplishments: Eliminated costly metal-coated caps defect and associated re-work, product rejections, field complaints

resulting in Quarterly savings of $250,000.

Reduced total % defective by 10% affecting 10 lines resulting in man/ hour & savings conservatively of $2,000,000 annually.

Performed & utilized additional capability studies to further reduce non-conformant product improving line yield and

bottom line profits in combination with the project effort – $150,000.

EDUCATION AND TRAINING HIGHLIGHTS

ALMEDA UNIVERSITY: Major: Bachelor of Science in Quality Management

WESTCHESTER COMMUNITY COLLEGE: Major: Electronic and Automotive Technologies

HONEYWELL: Certificate: Six Sigma Green Belt.

QUALITY GURUS Certificates: Six Sigma, ISO 9000, 1401 & Internal Auditor.

AMERICAN SOCIETY OF QUALITY CONTROL: Certificates: Statistical Process Control, Total Quality Management.

QA REGULATORY COMPLIANCE CONNECTION: Certificate: 21 CFR FDA Quality System Requirements Training.

MITUTOYO CORPORATION: Certificate: Mechanical Instrument Calibration

MID WESTCHESTER OCCUPATIONAL CENTER: Certificates: Semiconductor Technology, Digital Electronics,

Microcomputer Architecture, Telecommunications.

ROCHEAMBEAU TECHNICAL SCHOOL: Certificates: Electricity, Electronics, Assembly, Wiring, Harnessing.

49th QUALITY CONGRESS: Seminars: Total Quality Management, Problem Solving, Change through

Empowerment, Reducing Variation, Improving Quality Data, Next Step Control Charts.

WESTERN CONNECTICUT STATE UNIVERSITY: Lecture: The New Economics by W. Edwards Deming, Ph.D.

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