Violet Berecky

Westlake, Ohio

904-***-****

acx9gn@r.postjobfree.com

Education:

Cleveland State University, Cleveland OH

Bachelor of Science, Physics major

American Society for Quality Certified Quality Engineer (CQE)

US citizen

Professional Background

Work History:

Quality Engineer – Aerotek Inc. Berea KY (5/2014-present)

Contract Position at Hitachi USA, automtive suppliet. Review and maintain Quality Control Plans, Inspection Process Sheets, work instructions, FMEA's, and PPAP documents to customer requirements and TS16949.

Senior Quality Engineer – Externetworks Inc, Warsaw IN (11/2014 – 2/2015)

Three month contract at Zimmer Inc, Class III medical devices. Responsible for leading CAPA Teams of cross-functional resources, assuring products conform to established requirements and standards (ISO 13485, ISO 9001, 21 CFR 820.100 ) through CAPA Activities, including audit, inspection, and testing. Investigate, implement or verify effectiveness of CAPAs, i.e. creation and updates of procedures, work instructions, forms, inspection sh(eets, protocols, prints, reports, test methods, validations, execution of audits, trending of quality data such as complaints, NCR or scrap, implementation andverification of effectiveness (VOE). Collaborate with client's subject matter experts and external resources, i.e. suppliers. Used Enovia and TrackWise for CAPAs.

Supplier Quality Engineer – Aerotek Inc, Cleveland OH (09/2013 – 8/2014)

One year contract at Invacare Co, Elyria OH. Class I medical devices. Supplier development activities to drive higher level performance with identified suppliers by investigating customer complaints, reviewing SNCTs, CAPAs, CARs to follow up on preventative supplier action. Conducts desk audits, Owned supplier improvement for assigned suppliers through the internal and supplier CAPA process and identification of supplier needs to conform to ISO 13485, ISO 9001, 21 CFR 820.100. Experienced in use of statistical tools/analysis and techniques for quality management, Microsoft Office. Lotus Notes, Oracle, TrackWise.

Quality Engineer – Infotree Services, Moline IL (08/2012 – 09/2013)

Contractor Quality Engineer at John Deere Harvester Works, East Moline IL Responsible for product quality and reliability, manufacturing output and continuous improvements in a combine factory. Drove product improvement initiatives, lead continuous improvement teams for CAPA projects. Led and coordinated activities between current product engineering, operations, quality and customer support team. Supported the Quality Management System (QMS) policies and procedures. Developed document sheets and work instructions. Supported all internal and regulatory audits to ISO 9001. Identified root cause, and implemented corrective actions using quality processes. Drove changes to design engineering regarding issues impacting product quality. Supplied technical assistance for warranty

Violet Berecky resume page 2

claims. Verified supplier manufacturing processes (control plans, assembly instructions, etc.) Identified and resolved supplier quality problems.

Provided technical leadership to ensure improvements in the following: Statistical Process Control (SPC), Total Quality Management (TQM), Quality Function Deployment (QFD), CAPA, Design of Experiements (DOE), Failure Mode and Effects Analysis (FMEA)., 8D, LEAN, PDCA, fishbone, mistake proofing, MRB, root cause analysis, PPAP, NCCA, and Safety. Knowledge of product models, GD&T, welding blue prints and assembly drawings. Experienced in use of statistical tools/analysis and techniques for quality management, SAP, and Microsoft Office.

Test Scoring Supervisor - Pearson Educational, Inc, Jacksonville, FL (2/2003 – 6/2012)

Led teams of 35-75 onsite and offsite scorers and provided support in matters of content for multiple projects and customers to procedures and specifications required by ISO 9001. Provided technical expertise and training, and participated in preparation of training materials. Maintained up-to-date record of all scoring decisions and updated scorers as required. Monitored team to measure, review and report on scorer productivity, accuracy, reliability and performance to established targets. Maintained team training records and provided additional training as required. Worked with Scoring Directors to monitor and document performance issues with professional scorers, and to identify, recommend, initiate and direct improvements of the department quality program. Lead field testing team. Monitored work flow and supplies.

(1988-2003 gap – stay-at-home parent.)

Quality Engineer/Analyst – Goodrich Landing Gear Co, Cleveland OH (1986-1988) now UTC Aerospace

Performed quality data gathering and analysis. Developed and analyzed statistical data and specifications for product and process standards. Created statistical quality systems, such as trend analysis to control and/or improve processes. Performed quality audits of processes, products and workstations, trend analysis, quality planning. Provided root cause analysis and defect prevention, including evaluating claims determining root cause and assisting in identifying and implementing corrective and preventative actions, CAPA, and training new associates in quality inspection procedures. Participated on QC teams.

Receiving Inspection Supervisor - Rockwell International (Meritor), Ashtabula, OH(1984 – 1985)

Supervised Receiving Inspection and metallurgical laboratory for a truck brake manufacturer. Resolved product quality issues related to processes, equipment and product design. Drove continuous supplier product quality improvement through audits, corrective actions, lead supplier qualification. Supported manufacturing regarding any issue related to non-conformities. Lead and monitored corrective action implementation for issues related to suppliers. Monitored vendor performance and determined vendor/contractor selection based on performance, cost, safety and quality service requirements.

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