Engineer Quality

Theodora Zugajewicz

Certification

• American Society for Quality (ASQ Member)

• Certified Lead Auditor (International Registered Certified Auditors, IRCA)

• Certified Green Belt

Core Competencies

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Production Leadership Attention to Detail

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Quality Standards Design Engineering

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Cost Control and Reduction Lean Manufacturing

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Problem Analysis and Resolution Process Review and Improvement

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Vendor Relationship Management Team Building

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Minitab Internal and External Auditor

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Agile PLM Software Project Management

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ISO 9001 Training and Development

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TS16949 Excellent Communication Skills

• ISO 13485

Professional Experience

Jarden Consumer Solutions, Boca Raton, FL 3/2011 – 12/2012

Senior Quality Assurance Engineer (Health and Wellness)

• Ensure Product Start Authorization (PSA) for Health Care Devices meet customer and regulatory requirements; in

addition, develop product specification, Qualification Matrix.

• Direct Asia teams to verify supplier corrective actions and ensuring supplier’s quality systems meet standards.

• Identify Critical to Quality parameters, and conduct gap analysis for third-party testing and customer requirements.

• Prevent product launch into the market due to insufficient supplier corrective actions.

• Complete design reviews for all proto type builds, predict reliability warranty percentages, and conduct technical

capability review of new suppliers.

• Provide on-going technical support to business unit to lower monthly warranty numbers.

• Determine risk associated with testing / inspection and develop reliability / performance test plans for air purifiers,

heating pads, cold packs, scales, and pelvic muscle trainer.

• Execute in house quality functional deployment (QFD); design reviews, design Assurance Phase Gate

scorecards, as well as conduct system failure mode and effects analysis (SFMEA), Gauge Repeatability and

Reproducibility (GR&R), and design failure mode and effect analysis (DFMEA). Maintain ISO 13485 records for

external audit.

• Prohibited two projects from initial shipping through the calculation of “Z-bench numbers” saving significant

warranty returns.

Office Depot, Boca Raton, FL 04/2008 – 03/2011

Senior Quality Engineer (Supplies)

• Ensure products meet Food and Drug Administration (FDA), Federal Communications Commission (FCC),

Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA) regulations

by collaborating with suppliers and Office Depot Asia teams addressing Quality issues.

• Lead re-design of Factory Quality Audit documentation focusing on luggage, seating, writing instruments, and

shredders.

• Verify customer complaints, document corrective actions, and conduct post-purchase testing at third-party labs.

• Lead Oracle 11i Quality module development team to create 52 Collection Plans and document procedures for

quality engineers’ usage.

• Conduct comparison studies providing merchants accurate quality data for vendor selection.

• Perform in-house Artwork Review ensuring accuracy for customers to select products.

• Recovered $350,000 in charge backs for one product according to the 2010 analysis.

• Conduct in-house testing in preparation of Line Review for supplier selection.

Motorola, Plantation, FL 01/1994 – 03/2008

New Product Introduction Sourcing Engineer 2007 – 2008

• Lead New Product Introduction – Supply Readiness function for a new product activity, focusing on the electrical

side of programs.

• Met cost, quality, and scheduling goals for each assigned handset through working across organization

boundaries.

• Collaborated and worked closely with development engineering, category management team, suppliers, and

Supplier Development Engineer (SDE) teams qualifying material.

• Managed supplier and supply chain issues, supplier selection, and cost plans achieving cost reductions.

Component Technology Engineering 2005 – 2006

• Successfully led the assurance of Motorola’s supply chain quality determining purchased item qualification

requirements during initial assignment of component.

• Provided lead role in identifying quality requirements for Motorola’s purchased materials.

• Interfaced between design engineering and supplier during supply chain material qualification process.

• Supported Connected Homes bringing Component Technology Engineering to their organization within first ten

months.

• Conducted resource analysis for Connected Homes and efficiently analyzed needs.

Supplier Quality Engineering 1994 – 2005

• Effectively led several supplier assessment and audit teams.

• Organized requirement documents and implemented current material corrective action reports (MCAR) and

iDEN’s Waiver systems.

• Interfaced with Development Engineers, Manufacturing Engineers, and Suppliers across Asia, Europe, and the

United States, resolving line down, and high yield loss issues.

• Drove supplied material issues for root-cause analysis, corrective action, and cost of poor quality, recovered in

excess of $5,000,000 over a four-year period.

• Supported internal and external audits such as KEMA, BABT, ISO, QSR, TL9000, and Sterling.

Education

• Master of Business Administration Global Management University of Phoenix

• Bachelor of Science, Information Technology (magna cum-laude) University of Phoenix

• Associate of Science, Electronics Engineering (magna cum-laude) American Trade Institute

Skill Summery

Quality Engineer with expertise in management and manufacturing functions, cost avoidance, internal and external audits,

multi-cultural environments, process validation, problem solving, quality systems, and program management. Additionally

knowledgeable in top medical devices such as weight scales, pelvic muscle trainer, blood pressure machinery, heating

pads, and air purifiers. A top team member and individual producer skilled in developing exceptional vendor relationships

through attention to detail, subject-matter expertise, personal commitment, and technical knowledge.

Highly experienced Engineering Professional with a record of success leading diverse engineering teams and projects. An

independent thinker who effectively utilizes interpersonal and analytical competencies to successfully overcome the

challenges of cross-departmental communications, while effectively managing cross-functional teams, and skill sets.

• Highly focused on organizational missions while positively impacting bottom-line and group performance. Quality

engineering professional with exceptional technical experience, expertise medical device background, and

possessing extensive knowledge of the processes, procedures, and policies necessary to consistently produce a

superior product and service.

• Able to remain calm and work well in high-pressure situations, constantly seeking new challenges, a driven

individual with both a strong work ethic and the desire to exceed expectations. Always on schedule and under

budget, detail-oriented, able to prioritize and handle multiple tasks while achieving project goals.

Contact this candidate