Scott A. Markovich

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

Valparaiso, IN 46385

219-***-**** cell

e-mail: acr6vn@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

ASQ Certified, Quality Engineer (CQE), Six-Sigma Black Belt (CSSBB) and Auditor (CQA) with experience in FDA (21 CFR Part 820) & ISO 13485, QS and ISO 9001 quality systems, strong analytical skills with the patience and persistence to get the job done correctly. Strengths include, SPC, Lean Manufacturing, six-sigma concepts (SMED, Poka-yoke, 5S, Kaizen and cellular mfg.) and Visual Work Instructions

ADDITIONAL SKILLS

TPS (Toyota Production System) trained. (UGN)

Excellent communication skills at various levels of an organization.

Computer literate in: Word, Excel, PowerPoint & Auto-Cad.

Basic knowledge in CNC machining (G-code)

CAPA/VOE training and use

Skill in line-balancing techniques, Takt times and machine capacities. (UGN)

Understanding and implementation of Statistical techniques (SPC, probability, DOE, ANOVA)

Working knowledge of GD&T, FAL, GRR and Capability requirements.

PROFESSIONAL WORK EXPERIENCE

Zimmer Corporation Jan 2004 to Sep 2015

Quality Engineer Orthopedic Medical Devices

Duties & Accomplishments

Launched orthopaedic implants an instruments using Design (DFMEA) and process (PFMEA) risk analysis. FDA 510K approval.

Strong interpretation of GD&T and weld requirements,

Determined inspection gage selection for attribute/variable inspection of products.

Lead design and process CAPA’s through to VOE.

Generated gage repeatability and reproducibility studies using Mini-Tab software.

Reviewed and created visual work instructions and procedures.

Generated process capability (CPk) analysis for new and legacy processes.

Worked with product development on quality control/inspection plans for new products.

Worked with suppliers on new product inspection and control plans.

Interfaced with Research, Development, Manufacturing, Sourcing, Inspection and Regulatory personnel.

Investigated customer complaints leading to MDR submissions. (FDA)

Ashland Products, Lowell, IN May 2003 – Dec 2003

Quality Engineer Plastic injection molded window Accessories

Duties & Accomplishments:

Trained associates on SPC fundamentals.

Implemented manual SPC data collection method.

Performed ISO 9000 compliance assessment.

Learned, implemented, and taught the Powerway Quality Management program to associates.

Performed capability studies on transfer parts from parent company.

Andrew Corporation, Orland Park, IL 2000 – Apr. 2003

Quality Engineer Broadcast TV antennas & RF transmission line

Duties & Accomplishments:

Coordinated corrective actions for complaints through 8D problem solving techniques.

Developed product control plans to identify key process variables for quality control.

Maintained PPM (Parts per Million) & scrap data for analysis by business unit managers.

Performed scheduled internal audits of other departments to ISO 9000-2000 standards.

Assisted purchasing in evaluating supplier selection & supplier development program.

Obtained ISO 9000-94 & 2000 certification through BSI.

Developed a basic understanding of Six-Sigma Green Belt functions.

UGN, Inc., Chicago Heights, IL 1996 - 2000

Process Engineer Interior automotive parts – sound damping

Duties & Accomplishments:

Developed visual work cells and quality standards for assembly workers.

Used cycle time reduction (takt, SMED, Kaizen, cell layout) to meet production demands.

Assisted R & D in developing new products or improved manufacturing techniques.

Customer / supplier interaction on quality problems and requirements.

Assisted in control plan and FEMA development for automotive products.

Trained associates in SPC (Control charts, measles charts, checklists, and histograms).

Implemented visual work instruction and color code to assist production.

Reduced material costs and cycle times by 25% using cycle time reduction techniques.

United Tractor Co., Chesterton, IN 1995 - 1996

Quality Manager In-plant tractor assembly

Duties & Accomplishments:

Coordinated all customer warranty complaints and corrective actions.

Assisted in developing efficient assembly procedures.

Organized assembly flow to increase production > 100 % &. reduce quality defects by 50%

AM General Corp., Mishawaka, IN 1993 - 1995

Quality Engineer Production of “Hummer” RV vehicles

Duties & Accomplishments:

Investigated and corrected supplier and assembly line is.

Performed weekly process audits on the production line.

Improved supplier quality for chassis & diesel fuel / injector problems.

Improved front-end alignment technique for improved quality.

Diverco, Inc., Harvey, IL 1986 - 1993

Quality Manager Government contracting and after-market automotive parts.

Duties & Accomplishments:

Successfully directed the assembly, testing, and packaging of manual transmissions, transfer cases and replacement parts for 2-1/2 ton military vehicles.

Utilized MIL-STD-105 sampling plans for inspection of incoming material.

Developed effective assembly and quality manuals for production and government requirements.

EDUCATION

Masters in Quality Management, Eastern Michigan University – Ypsilanti, MI (2011)

B.S. Degree, Industrial Engineering Technology, Purdue University Calumet - Hammond, IN

Associates Degree, Supervision, Purdue University Calumet - Hammond, IN

Certified Quality Engineer, Six-Sigma Black Belt & Auditor, ASQ

Contact this candidate