Engineer Quality

Wanda Liz Matos-Berrios

Kingsport, TN ***** 787-***-**** *****.********@*****.***

linkedin.com/in/wanda-liz-matos-berr%C3%ADos-247a1544/ Engineering Professional

Operations Quality Engineering – Project Engineering – Process Improvement Engineering Engineering Management

Quality Assurance

Project Management

Lean Manufacturing

Industrial Engineering

Time Management

Process Improvement

Team Leadership

Problem Resolution

Highly analytical and innovative with experience developing, suggesting and prioritizing Lean-Six Sigma improvement projects.

Ability to implement and monitor diversified activities to maximize the effectiveness of resources, continually improving operational processes. Solid understanding and knowledge of improving quality and production processes in fast-paced manufacturing environments.

Strong achiever in areas of continuous improvement, efficiency, cost, quality, safety, problem solving, teamwork, and technical documentation. Articulate communicator with the ability to work in fast-pace and multitasking manufacturing environments.

PROFESSIONAL EXPERIENCE

Stryker Arroyo, PR 2019

STAFF QUALITY OPERATIONS ENGINEER

Spearheaded and scheduled work requiring modification of standard engineering techniques, procedures and criteria, determining schedule and budget requirements for project to coordinate efficient work. Led, controlled and accomplished EU MDR project following new regulations required from Europe Region to be on board on 2020. Conducted internal audits from each unit of the company, including Injection Molding, Machine Center, Blood, Cement, and Sport Medicine.

• Estimated materials costs and sourcing requirements to determine project feasibility.

• Implemented corrective actions within time constraints by evaluating completion tasks by Supervisors, Quality Engineers, Manufacturing Engineers and Associate Leaders.

• Efficiently evaluated possible changes based on new medical devices requirements, such as change of procedures, labels, and packaging of products.

Stryker Arroyo, PR 2017 - 2019

QUALITY OPERATIONS ENGINEER

Held bottom line accountability for developing, applying, revising and maintaining quality standards for processing raw materials or components into partially finished and/or finished products at the Injection Molding and Machine Center Unit. Achieved quality excellence in each related procedure while developing and submitting engineering changes like ECOs, TCOs, MCOs and ECRs from particular areas within all complimentary steps. Provided high level leadership in development, review and approval of process and equipment validation/ qualification also in manufacturing processes for existing and new products. Orchestrated technical support to Quality Control Inspectors, including evaluating performance of Inspectors based on pre-established performance parameters.

• Analyzed reports and recommended corrective actions, conducting failure analysis of product and processes, including problem solving efforts, reliability design improvements, product failure trending, and training.

• Developed and implemented SOPs as well as completed associates’ trainings in compliance with company quality standards and ISO 9000 regulations.

• Formulated and continually updated control plans in accordance with Unit requirements. Stryker Arroyo, PR 2017

ADVANCED PROCESS QUALITY ENGINEER

Wanda Liz Matos-Berrios

Page 2 • Career Progression (Cont.)

Successfully managed all phases of an operational execution project form inception to completion within budgetary and time constraints in the manufacturing areas called MES (Manufacturing Execution System), using Delmia Apriso as the principal software. Performed diversified activities, including conducting cost analysis, adjusting budget offers with suppliers, making needs assessments of the areas, adding new suppliers while serving as focal part of Continuous Improvement department. Communicated effectively Project Managers and Finance for the use of assigned account developing Requisitions/PO's related to CER's Projects.

• Achieved the goal of transform areas paperless by 100% eliminating scrap significantly, reducing production time 50% and increasing 75% of the productivity.

• Identified potential failure modes and risks, as well as developed and implemented quality assurance practices and controls in multiple new product developments and/or manufacturing transfers. Pfizer Consumer Healthcare Guayama, PR 2014 - 2017 QUALITY ENGINEER AT TECHNICAL SERVICES DEPARTMENT

Acted as prime technical contact on contracts and projects interacting with senior external personnel on significant technical matters. Delivered expert technical advice in resolving complex technical problems.

• Developed Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports Support.

• Completed validation responsibilities of projects within schedule, budget and quality constraints while working with project managers.

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Additional experience: Quality and Lean Six Sigma/Capstone Project (2012 to 2013) at Medtronic/Villalba, PR; Ergonomic and Work Design Project (2012) at Cybertech Guaynabo, PR; Occupational Safety and Health Intern (2011 to 2012) at Eaton Cuttler & Hammer/PR; Packaging Engineer Assistant Intern (2011) at Biomet/Guaynabo, PR; and Business Improvement Design Consulting Project (2018 to 2020) at Do It Best/Barranquitas, PR. TECHNICAL PROFICIENCIES

Agile Oracle Excel PowerPoint Minitab MS Project Microsoft Office Trackwise EDUCATION AND CERTIFICATIONS

Polytechnic University of PR, accredited by ABET (Accreditation Board for Engineering and Technology) San Juan, PR Master’s Degree in Engineering Management – (2019 to Present) Inter-American University of PR, accredited by ABET (Accreditation Board for Engineering and Technology) Bayamon Campus

Bachelor’s Degree in Industrial Engineering

Certifications

Lean Six Sigma BLACK BELT Certified CIAPR Validations Engineer Certified ISO 9001 Executive and Management

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