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Manager Quality

Location:
Plano, TX
Posted:
April 30, 2016

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Resume:

SUMMARY

Expertise in trace organic, ultra-trace inorganic measurements, microscopy, materials characterization. Expertise in quality management, RCA/CAPA, FMECA, quality costs, regulatory documentation and training. Saving quality costs, finding root causes to real problems and implementing aligned solutions. Listening, building healthy working relationships and supporting team members. Versatile leader with social intelligence and ownership attitude.

EXPERIENCE

Analytical Chemist and Lab Manger, Encore Wire, McKinney, Texas; Manufacturing of household wire. 2014 to 2015 Developed methods for analysis of wire insulation, copper, aluminum, lubricants, slag, wastes and other production materials. Analyzed incoming materials, MRB materials investigation, new PVC and XLPE formulations, process engineering and maintenance concerns. Consulted with new Quality Manager on setting up inspection and RCA/CAPA. Used SEM/EDAX mapping to discover defects in aluminum alloy rod resulting from improper casting. Solved RCA/CAPA questions with JEOL SEM/EDAX, Bruker DC Arc, PerkinElmer spectrum FTIR with spotlight microscope, PerkinElmer clarus GC/MS with CDS pyroprobe, PerkinElmer Optima ICP-OES with ESI SC4 auto-sampler, NuAire NU156 hood, Milli-Q water system. Designed a new laboratory for trace analysis of metals in various unknown samples. Collaborated on PVC formulations using FTIR and SEM

Quality Manger, Longwood Elastomers, Brenham, Texas, Heavy manufacturing of elastomeric and plastic parts. NOTE: plant subsequently sold by holding company to Westinghouse 2013 to 2014

Managed Quality Department of 20 direct reports with 3 shifts. Planned and directed improvement projects for the facility representing thousands in cost savings while under budget restrictions of holding company. Wrote and revised ISO work instructions to improve MRB, RCA/CAPA, reliability testing, FMEA and other critical QMS elements. Created professional training and coaching program for Quality Dept. Staff. Gained support of Engineering Manager and trained process engineers in RCA/CAPA and pFMECA saving thousands in training and project costs. Responded daily to customer concerns with status of managed RCA/CAPA projects. Reviewed daily quarantined suspect materials and managed disposition with Materials Review Board.

Quality Manager, Lab Supervisor, Kelly Scientific contract to SHINESTU Silicones, Freeport, Texas

Specialty Chemical Manufacturing by US division of a Japanese corporation 2012 to 2013

Maintained the monthly budget for laboratory and quality department. Produced COAs of product lots for daily shipments. Obtained Class D Potable Water License. Optimized ASTM method for TOC of wastewater using Shimadzu TOC instrument, optimized parameters to obtain control target values, optimized preservative and storage prior to measurements and implemented SPC to gain good agreement with reference lab results. Improved accuracy and precision of auto titration method for hydrolysable chlorides in product using a Mettler Toledo system, repaired and optimized settings, optimized reagent delivery and established SPC for production monitoring. Established routine use of performance, diagnostic standards for Agilent GC-TCD resulting in improved reliability, accuracy and precision of product measurements. Estimated accuracy, precision and uncertainty of measurements using independently prepared control samples and SPC run charts. Initiated NIST traceable check standards and control charts for lab metrology and QC.

QUALITY CONSULTANT, ROE Dental Lab, Garfield Heights, Ohio, Dental Device Manufacturing 2011 to 2012

Conducted internal audits to standard DAMAS (Dental Appliance Manufacturing Audit System) in anticipation of FDA requirements for dental appliances. Wrote highly effective work instructions that reduced rework and improved training effectiveness of new employees. Established opportunity analysis and improved defect database resulting in successful RCA/CAPA projects. Wrote procedures for CAD/CAM operations in fabricating surgical stents for implants. Eliminated clogged sinks, saving thousands in plumbing maintentnance. Reduced product variation in isotropic polishing saving thousands in rework. Trained technicians and supervisors in RCA/CAPA process, eliminating root causes in mis-press of ceramic crowns.

NOTE: Dental School DMD program at Case Western Reserve SDM (2005 – 2011)

SCIENTIST, QUALITY OFFICER of NASA Life Sciences labs, Wyle Laboratories, Inc., Houston, Texas

Contractor to NASA JSC Life Sciences Laboratories 1999 to 2005

Recognized by operations management as resident expert on laboratory quality systems. Established a statistical process control (SPC) program for GC, GC/MS and FTIR measurements of VOCs and permanent gases in spacecraft air and off-gas test samples. Dramatically improved precision of GC measurements of air and off-gas samples using SPC to monitor and optimize critical operating parameter. Identified root causes of variation in GC and GC/MS measurements using SPC. Implemented accuracy estimation for VOCs using independent VOC standards for estimation of uncertainty similar to US NAVY submarine program. Developed, validated and transferred an analytical method for GC-PDHID measurements of carbon monoxide in flight hardware off-gas samples. Provided final reports to NASA customer on analysis of air samples from Shuttle and Space Station. Provided methods development, optimization, validation and transfer of FTIR with gas cell for VOC mixtures in air.

LABORATORY MANAGER, ANALYTICAL CHEMIST, MEMC-PASADENA, Pasadena, Texas 1997-1998

Developed, optimized, validated and transferred GFAA and ICP-MS methods for ultra-trace metals in granular poly-silicon. Trained technicians in clean-room operations. Designed multi-million dollar clean room laboratory for high volume analyses of granular poly-silicon product. Implemented particle counting with statistical process control. Conducted drumming study that demonstrated metals variation due to wash-out, stabilization and wear out of silicon process lining.

SENIOR SCIENTIST, chemical hygiene officer, ISO lead auditor, Lockheed-Martin, Houston, Texas

Contractor to NASA JSC Engineering Laboratories 1989 to 1997

Solved over 200 non-metallic materials characterization, contamination and failure analysis problems relating to diverse materials failures including coatings, plastics, elastomers, fabrics, dyes, adhesives, lubricants etc. Supported numerous root cause analysis projects for NASA, JSC. Developed, optimized and validated methods for materials analysis using TGA, GC, IC, FTIR, GC/FTIR/MS. Identified thermal stripping of fatty acid binders from magnetic tapes as mode of failure for Shuttle data recorders, saving and estimated $10M per flight. Identified contamination sources in Moon Rock Clean Room and recommended particle counting, SPC of measurements, sources of acids, Teflon and PFE utensils, fan powered HEPA prep carts. Served as ISO9000 Lead Auditor.

EDUCATION

MBA, MANAGEMENT, University of Houston - Clear Lake, Houston, Texas

MS, ANALYTICAL CHEMISTRY, University of Houston - Clear Lake, Houston, Texas

BS, CHEMISTRY, ACS accredited, Department Scholarship Winner. Texas A&M - Commerce, Texas

NOTE: Dental School at Case Western Reserve SDM (2005 – 2011)

CERTIFICATIONS AND LICENSES

Lead RCA/CAPA Investigator, Lead Auditor ISO 9001-2008, Certified Quality Engineer (ASQ), Certified Quality Auditor (ASQ), Expanded Function Dental Auxiliary licensed in Ohio, Class D Potable Water license in Texas, and transportation worker identification card TWIC

SKILLS AND KNOWLEDGE SUMMARY

ANALYTICAL Methods Development, Optimization, Validation, Transfer according to ICH guidelines.

Metals Trace techniques Dionex HPLC-IC, Perkin-Elmer GFAA, ICP-OES, Agilent ICP/MS, DC-Arc,

Sample Prep HEPA ultra-trace sample prep and clean room design, Millipore Direct 16, Milestone Microwave digestion of samples for metals analysis, Metallurgical sample preparation

Microscopy JEOL 6610 SEM/EDAX element mapping, PE FTIR with mapping, optical techniques

Chromatography Varian, Finnagan, PerkinElmer, Agilent and Shimadzu GC, GC/MS, HPLC,

Organic Spectroscopy FTIR BioRad with KnowItAll, and Nicolet FTIR with ATR, gas cell for VOCs, FTIR with microscope and mapping, NMR characterization of small organics, UV/vis assay of serum iron and iron binding capacity, mass spectroscopy, spectroscopic identification with NMR, UV, FTIR, MS

Thermal analysis of materials DSC and TGA, of plastics,

Electrochemical Shimadzu TOC of wastewater, Mettler Toledo auto-titration, coulometric titration

Other extraction by soxhlet SPE, thermo extraction and pyrolytic sampling, Homogeneity and Stability studies for test compounds, Air analysis for VOCs by GC/MS

REGULATORY TCEQ reporting, SEMI and ISO9001 standards, cGMP, FDA requirements for RCA/CAPA, chemical hygiene officer OSHA 29CFR1910.1450, Texas potable water operator, DOT labeling, ICH guidelines

QUALITY Lean Six Sigma (ASQ), Biomedical Auditor (ASQ), Lead RCA/CAPA investigator, Lean six sigma tools FMEA, cGMP, ISO13485, ISO17025, Mil-HDBK217, Mil-Std1520, 1629, 4566, APQP, PPAP & control plans, ICH Analytical Methods Validation, expert process flowcharter, expert interviewer and auditor

CONTAMINATION CONTROL Clean room design & sample prep techniques, particle counting, sterile technique, clinical microbiology culture and identification

MILITARY

United States Air Force, Medical Laboratory Specialist, AFSC 90450, E4. Honorable Discharge; medical technologist by examination.

ORGANIZATIONS

American Society for Quality, American Chemical Society, American Society of Portrait Artists



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