Resume of Six Sigma Black Belt Manager

Title
Six Sigma Black Belt Manager

Primary Skills
Analytical, solution-driven Quality Project Manager / Six Sigma & Reliability Expert with over 8 years experience

Location
US-NJ-Fair Lawn

Posted
Apr-03-07

SUMMARY
Analytical, solution-driven Quality Project Manager / Six Sigma & Reliability Expert with over 8 years experience of outstanding yield products improvement. Deeply skilled at developing and optimizing specifications for new products and manufacturing processes. Proven ability to apply Six Sigma and LEAN techniques for process optimization. Demonstrated the highest level of expertise in SPC system creation and implementation. Diverse background in reliability concepts including reliability predictions accelerated testing, and data analysis. Highly motivated, assertive and committed to excellence. Dedicated leader and team player with effective troubleshooting and problem solving skills.

Areas of expertise include:
* Six Sigma / DFSS Methodologies
* Statistical Process Control for Manufacturing
* Product Reliability for Manufacturing
* Process Improvement & Optimization
* DOE (Design of Experiments)
* QSR, ISO11608, ISO9000 Quality Management System
* LEAN Manufacturing
* Measurement and System Analysis
* Exploratory Data Analysis
* Process and Reliability Modeling
* Product and Process Comparisons

PROFESSIONAL EXPERIENCE
BECTON AND DICKINSON & CO, - FRANKLIN LAKES, NJ 2004- PRESENT
DIABETES CARE SEGMENT

Position held: Quality Project Manager / Six Sigma & Reliability Expert
Project manager for insulin delivery system products. Provide Quality Engineering functionality to the development of BD Diabetes Care products. Responsible for establishing guidance on design control activities (including design input, design output, reliability engineering applications & processes). Collaborate with R&D and Operation to validate new/modified processes. Create quality specifications, plans, test methods, protocols and inspection techniques. Train senior management and engineering teams in the efficient use of the Applied Statistics & Six Sigma concepts. Provide reliability engineering expertise integrated into BD Quality Engineering Manufacturing for product and process improvement.

* Established global inspection process across all BD Diabetes Care plants. Reduced sample size for testing process in BGM QA Lab by 9 fold with no quality risk.
* Led Production Process Control Monitoring strategy (SPC System) for BD manufacturing plants in Ireland. Successfully completed SPC system pilot implementation for production line of "Safety Syringe" products.
* Pioneered innovative stability program to forecast shelf life for alcohol swabs product utilizing Accelerated Age Testing techniques. Significantly streamlined product release process to Canadian market.
* Developed and implemented Test Method Validation Guideline for the entire Diabetes Care Unit applying Six Sigma Methodology. Successfully achieved 100% compliance with US FDA and European regulations for inspection and measuring processes.
* Provided Quality Continuous Engineering support for Lancet/Lancer products (Validation:IQ/OQ/PQ, CAPA, HHA, Complaints and NCMR activities).
* Established reliability programs for BGM and Insulin Delivery Platforms ensuring usable life of the product at the earliest stage of design.
* Managed quality activities of BD Pen Needle Compatibility Study. Developed direct and executed universal strategy for dose accuracy testing that ensured 100% of correct dose delivery to End-User.
* Analyzed operational, test and validation data to establish optimal specifications and performance standards for new/modified products.
* Supported Marketing and R&D with new product specifications development process applying statistical tolerance method. Managed of DFMEA/AFMEA and Risk Management Plan.


APPLIED MATERIALS INC, - SANTA CLARA, CA, 1998 - 2004
Developer and manufacturer of semiconductor equipment

Positions held: Sr. Quality Engineer / Six Sigma & Reliability Expert; SPC Manager

Statistical Process Control (SPC) system manager. Responsible for releasing optimal specifications in R&D and Manufacturing phases. Participated in Design Reviews, New Products Release Readiness Process and assembly / integration of the First Prototype Tool in MFG. Provided yield improvement of critical modules both for Manufacturing and Material Suppliers. Collaborated with R&D, Operation and Materials to validate processes and products. Conducted root-cause analysis, process failure identifications, and failure rate predictions supporting advanced technologies. Responsible for ensuring reliability requirements through early design review, reliability prediction, and risk assessments. Built DOE models for new hardware and software products, processes, and facilities both for R&D and Manufacturing.

* Developed applied mathematical models "Quality Factors" and setting up meaningful specifications to separate between resourceful and ineffective products, resulting in over $2 million in single-year savings.
* Initiated Constructive Analysis Process that streamlined the new product release process from R&D to Manufacturing. Achieved an improvement in building of the first prototype tool with 5% ECR, instead of 30% before.
* Successfully developed and implemented unique SPC system for all product lines, which included individual charts for optical, mechanical and electronic modules, achieving 100% manufacturing process control.
* Optimized metrology product specifications for R&D and Manufacturing based on SPC data, utilizing DOE and statistical tolerance methods. Achieved minimum product NC's < 4 and total MRB cost < 1%
* Performed significant process improvements and optimized SPEC's for all product lines, which decreased adverse trends, applying advanced statistical and failure analysis techniques such as ANOVA, MANOVA, Failure Mode Effects Analyses (FMEA), Multivariate Regression, GR&R, Capability Analysis, etc.
* Dramatically increased supplier's product quality by positioning and executing meaningful specifications, and then closely monitoring their performance. Built and implemented SPC system at supplier's site, increasing their product yield from 35% to 87%.



EDUCATION AND CERTIFICATION
SILBERMAN COLLEGE OF BUSINESS, FDU, TEANECK, NJ
M.B.A., International and Pharmaceutical Management Concentration, (in-progress)
UNIVERSITY OF HAIFA, HAIFA, ISRAEL
FACULTY OF MATHEMATICAL SCIENCES
M.A., Reliability & Applied Statistics Science, 2004
Six Sigma Black Belt, 2003
B.A., Statistic Science, 1998


PROFESSIONAL TRAINING
* Manufacturing Reliability,
* ISO 9001 Quality Management System
* Design For Manufacturability
* AAMI QSR (21 CFR 820)
* AAMI Design Control (21 CFR 820)
* AAMI Risk Management



SOFTWARE SKILLS
* Windows XP/NT/95
* SAS
* SAS Enterprise
* JUMP
* ANSTAT
* SPC On-Line
* C/C++
* MS Office
* Outlook
* Project
* PowerPoint
* Visio
* Lotus Notes

LANGUAGES
Proficient English, Hebrew, and Russian


Certifications
See above


You must be logged in and have a current resume access subscription. Login or Register »

View all resumes in US-NJ-Fair Lawn »
View all resumes in US-NJ »

View other Six Sigma Black Belt Manager resumes, IT Manager resumes