Engineer Quality

SERGEY MIRONCHIK

E-mail: **********@*****.***

*** ****** **** . **** ******, IL. 60047 . Home: 847-***-****

PROFESSIONAL SUMMARY

Quality Professional with eight (13) years experience in the medical

device, automotive and aerospace industry. Responsible for all aspects of

the quality system. Management representative for ISO13485, customer

compliance audits, plant level improvement plans, implementation and

maintenance of the plant quality system. Experience has led to a thorough

knowledge of quality systems per CFR 820, ISO 14971,QSR, regulatory

compliance, product development, supplier quality, product manufacturing,

and data systems. Unique ability to analyze the problem, visualize a

process, and fully realize the solution.

PROFESSIONAL EXPERIENCE

January 2009- Present

Teleflex Medical Corporation, Kenosha, WI

Quality Engineer

. Participate in new product development and perform design verification..

. Coordinate teamwork efforts as Sustaining Engineering, Manufacturing and

Planning groups to assure CAPA opened and completed appropriately.

. Perform complaint investigations and provide complaint metrics for QBR

meetings.

. Implement Field Corrective Actions( FCAs) and product holds when

appropriate.

. Participate in Installation Qualification ( IQ), performing Operational

Qualification (OQ), Process & Product Qualifications(PQ).

. Apply statistical techniques such as process capability, DOE, linear

regression, confidence intervals, hypothesis testing and many other

statistical tools.

. Apply validation tools as Flow Diagram, PFMEA, Control Plan, Capability

Analysis, MSA studies.

. Facilitate Kaizen Events through Value Stream Mapping, developing Kanban

system and switching from Push to Pull system.

. Perform internal ISO 13485.

. Successfully completed transfer of Quality Management and Manufacturing

System of Surgical Instruments from Corporate plant to OEM facility.

. Integrated corporate Standard Operating procedures into OEM Facility

Document Control.

. Initiated and provided licenses, certificates and registration

documentation needed to register products in different world regions.

. Participated in developing new complaint reporting system for QEM

facility to meet CMDCAS, PAL, MDD requirements.

. Set up SPC station, installed software (InfinityQS) and trained floor

personnel

. Validated major supplier and internal processes as Heat treat, Gold

Plating, Laser welding & Passivation for surgical product.

. Performed Six Sigma projects as scrap reduction, improving lead time.

. Developed Process Layered Audit system.

. Provided necessary resources based on transfer project budget to support

quality and assembly areas.

. Developed skill set matrixes for new personnel, consistently supporting

cross training activities after transfer.

. Created multiple quality and manufacturing standard operational

procedures and work instructions.

June 2008 - October 2008

RGRay Corporation, Buffalo Grove, IL

Quality Assurance Engineer

. Supervised inspection staff.

. Point of contact with customers regarding quality issues.

. drove activities to reduce internal & external PPMs.

. Made disposition for nonconforming material

. Involved in advanced quality planning(APQP).

. Reviewed complete PPAP documentation.

. Established SPC activity including process capability study

. Perform Internal Audit per TS 16949.

. Followed up on corrective action.

. Responsible for receiving and following up on warranty claims.

. Responsible of developing and passing of quality plans to plant in

Mexico

April 2007 - May 2008

JD Norman Industries, Addison, IL

Quality Assurance Engineer

. Supervised inspection staff.

. Point of contact with customers regarding quality issues.

. Involved in advanced quality planning.

. Performed entire PPAP documentation (QS 9000 & TS 16949 standard).

. Established SPC activity including Process Capability Study

. Performing time studies and analyzing process to reduce set up & cycle

time.

. CMM programming (Programming PCDMS Browne & Sharpe).

. Involved in outside special processes audit and quality issues.

. Trained inspectors on GD&T and the use of inspection equipment.

. Performed reliability, probability and statistics reports

. Established and managing inspection gage calibration system.

. Designed special gaging (Poke-Yoke) to prevent quality issues during

process.

. Involved in external and internal audits.

. Involved in supplier development.

. Created IMDS data for PPAP & analyzing supplier's IMDS data.

. Monitored scrap charts and on time delivery for continuous improvement.

. Made disposition for quality nonconformance.

. Followed up with corrective action for customers. Issued SCARs.

October 2006-April 2007

Swiss Automation, Barrington, IL (contract)

QA Engineer

. Performed complete PPAP documentation (QS 9000).

. Trained inspectors GD&T and to use inspection equipment.

. Performed internal audit.

. Worked with suppliers to resolve quality problems

. Made disposition for nonconforming product

. Participated in Corrective Action meetings

. Developed and Maintained Gage calibration system

April 2006-October 2006

Line Craft Tool Company, Lombard, IL (contract)

Senior Quality Engineer

. Performed entire PPAP documentation (QS 9000).

. Performed internal audit.

. Kept up to date Control Plans, FMEAs and production routers.

. Analyzed Control, Run Charts and Histograms for continuous improvement

. Provided inspectors with training when needed.

. Monitored gage calibration database.

. Performed customer specific assessments

. Performed occasionally 1st piece inspection.

. Responsible for closing Nonconforming reports

November 2002 - April 2006

Amtec Precision, Elgin, IL

Quality Control Engineer

. Participated in advanced quality planning.

. Performed complete PPAP documentation (QS 9000 & TS 16949 standard).

. Performed SPC activity including Process Capability Study.

. Performed time studies and analyzing process to improve cycle time.

. CMM programming and inspection (Zeiss, Calypso, U-soft software).

. Responsible for outside special processes performing and certification.

. Trained inspectors GD&T and to use inspection equipment...

. Designed special gaging (Poke-Yoke) to prevent quality issues during

process.

. Performed internal audits.

. Involved in continuous process improvement program.

. Worked with customers and suppliers for quality improvement.

. Followed up with 8D Report/Corrective action for customers.

November 1997 - November. 2002

Frey&Weiss, Woodale, IL

Quality Control Technician

. Performed all stages of inspection process.

. CMM Programming and operating of Mitutoyo CMM.

. Performed manual inspection by using variety of inspection instruments.

. Preparing in-process gage set-ups for production processes.

. Reviewed inspection data during and at completion of production run.

. Assist production in troubleshooting discrepancies.

. Reviewed and modified inspection instructions.

EDUCATION

BS in Engineering of Technology and Machine Building at Technological

University of Belarus.

Continuing Education:

. Six Sigma Black Belt . ASQ Certified Quality Engineer . Lean

Manufacturing Trainer

. ISO 13485 Internal Auditor . Project Management . Statistical Process

Control Course . AutoCAD 2007 & SolidWorks . Internal Auditing for TS

16949 . Geometric Dimensioning and Tolerancing

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