Engineer Quality
Resume:
N. David Yahya
Pensacola, Florida 32503 Email: ****************@*****.*** Phone: 727-***-****
OBJECTIVE:
Seeking an Engineering position as Sr. Level Management or Plant Manager.
EDUCATION:
Texas A & M University B.S. Mechanical Design Engineer
(Minor: Quality Engineering)
SUMMARY OF QUALIFICATIONS:
Fifteen years of experience in various Manufacturing, Quality Engineering, Production Planning, Product Design & Development, and Engineering Management in Medical Device, Laser Printing and Automotive Industry.
Strong background in statistics and excellent skills in Quality Planning tools, System Design, Multivariate Statistical Analysis, Time Series Analysis, Statistical Process Control (SPC), Quality Management Systems (QMS), Design for Manufacturing (DFM), Design for Assembly (DFA), Lean Manufacturing, Advance Product Quality Planning (APQP), PPAP, Failure Modes & Effects Analysis (FMEA), Design Verification Plan & Report (DVP&R), Gage R&R, 8DTechniques, Benchmarking, Kaizen, Fishbone Diagram and Material Requirement Planning (MRP).
Compliance with following Regulations Standards: 21CFR820, ISO 9000, CE Mark, MDD, UL, IPC, and ISO 13485.
EXPERIENCE:
Pall Corporation Life Sciences Division, Pensacola, Florida March 2011 to Present
Sr. Level Process Engineer promoted to Unit Manager.
Managed process improvement projects that affected production through-put, and scrap reduction. ($1.5 million annual savings)
Participated in new product introduction to manufacturing, through establishing processes and equipment from User Requirements Specifications to machine fabrication followed by process validation and qualification protocol execution.
Managed a project to introduce new inspection vision system that improved media quality. ($3 million annual savings)
Team leader of cleaning validation project for reduction of Endo-toxin bio-burden throughout the manufacturing process. ($2 million annual savings)
Led SMED introduction to manufacturing to reduce changeover time. $1 million annual savings)
Led customer returns and complaints system. Reduced response time to complaint resolution to 4.5 days.
Led multiple projects for the installation and qualification of Media Vision Inspection System which greatly reduced customer complaints.
Led Project to install SPC Modules for X and Y Variables to be used to drive process adjustments and quick response in addition to trending capabilities.
Medical Device Experience: Smith & Nephew Wound Management, Largo, Florida
Dec, 2007 to 2010
Sr. Level Process-Improvements Engineer …. ($3Million Annual Savings)
Performed Process and Product improvements activities such as defect reduction projects to improve throughput, product quality and enhancing capabilities of Manufacturing Processes by introducing Poke Yoke measures. CAPA Projects.
Managing projects using Lean 6-Sigma methodology (DMAIC), data collection techniques & analysis using SPC Software packages such as Minitab and Quality Companion Project Management Software.
Interfacing with vendors to improve process Equipment, new tooling and fixtures needed for new product launches.
Work closely with Production Floor to identify areas that need improvements and waste elimination using Lean Six-Sigma tools such as DOE, Value Stream Mapping, FMEA, Fishbone Diagrams and process and product Reliability and Quality enhancements tools.
Performed retrospective and prospective Process and product Validation and Verification Projects including IQ, OQ, PQ and PPQ activities in accordance to Master Validation Plan and Risk Assessment Quality System.
Equipment Utilization Enhancement Projects such as 5 S, Change-over reduction SMED method and Mistake Proofing with yield of more than $300K annually.
Working closely with Teams to provide technical support for Safety, Purchasing for new vendor qualification.
Quality and Manufacturing Representative in new product launches Design Review Teams using Risk Analysis, design validation, Design input to Design output traceability, Device History Record File Creation.
Gage R&R studies, GNG Gauge. And fixture design.
Strategy Engineering Consulting (Dental & Medical Devices), Clearwater, Fl
2000-2007
Process Improvements Manager / Consultant Engineer
Implantable Dental Devices, Baxter
Elimination of Non–Value added work, and product quality improvement using methods, such as Kaizen Events combined with Lean Six Sigma Value-Stream Mapping, FMEA, Control Plans & SPC tools to analyze collected data and improve process Cpk.
Standards and SOP creation in compliance to FDA, GMP and ISO requirements.
Continuous process- improvements activities using Kaizen and Six Sigma projects teams.
Spearheaded monthly data reviews to identify production issues and developed resolution plan.
Identified root causes, analyzed and assisted in developing corrective action for manufacturing process.
Supported internal & external assessments, complaint investigations, recalls, CAPA, design and management review.
Performed Hazard Analysis, and Robustness Design Methods.
Participated in process verification and validation to ensure compliance of product manufacturing to FDA regulations
Linvatec Corp. (Medical Devices), Largo, FL 1998-2000
Manufacturing / Process Engineer II / Kaizen Facilitator
Supported new product launches, such as ablator electrodes and scopes and Bio-Implantable Screws, Powered Surgical Devices.
Continuous improvement principles added to new product at design stage to create smart defect-free products, DFSS
Supported existing manufactured products and quality improvement through defect elimination (applied Kaizen method to existing products)
Participated in process verification and validation to ensure compliance of product manufacturing to FDA regulations
Facilitated multiple Tiger teams for product quality and process improvements.
Hayes-Lemmerz (Wheel manufacturing facility for BMW & Mercedes) - BOWLING GREEN, KY 1995-1998
Manufacturing Engineer / Continuous Improvements Manager
Support of wheel assembly operation and non value added and defect elimination
Participated in new line layouts to accommodate new products and Improvement of existing assembly lines
Supervised new tooling and pilot runs for new products, and supporting new product launch
Assisted launch team with processors: Pp, Ppk, Cpk, Six-sigma, X-Bar, P-charts, Control charts & capability reports.
Assisted quality manager in conducting audits, control plans, inspection, & first piece inspection.
Performed R&R study, measurement study, gage calibrations & fixture study.
Involved in activities related to time studies, work method optimization and material handling.
Reduction of set-up time and quality improvements
LEXMARK International Group – Lexington, KY 1992 – 1995
Manufacturing/ Process Engineer
Assembly line layouts to accommodate new Optra Laser Printers and flexibility for mixed Modeling manufacturing.
Creation of product routing and assembly instruction diagrams and Charts
Participated in Quality Circle teams to eliminate defects and improve Quality and On-Time delivery
Served as liaison between Design Engineering and Manufacturing to eliminate defects and to implement changes to existing designs.
Quality improvement through statistical process control and POKAYOKE
Performed R&R study, measurement study, gage calibrations & fixture study.
Involved in activities related to time studies, work method optimization and material handling.
TRAINING:
Dimensional Control for Quality Quality System Auditing / Supplier Auditing
Quality Systems Inspection Technique (QSIT) Quality Assurance / Management
Quality System Auditing / Supplier Auditing Supply Chain Management
Robust Design (Taguchi Methods) Advanced Course
SKILLS:
SOFTWARE: PDM Software, AutoCAD, Graphic Design, Minitab, Simon, I-THINK, Comladd II, ALDEEP, IDEF Process Modeling, Infinity QS & QFD Plus.
GENERAL: Ms Office, Ms Access, Ms Project, and JD Edwards
PERSONAL:
U.S. Citizen, Bilingual.
Recently been accepted in the Master Program in Biomedical Engineering
References Available Upon Request
Contact this candidate