Quality Director or Quality Manager

Michael R. Goede

* ********** ***** *******, **** 45150-9696

Residence: 513-***-**** E-Mail: ******@***.*** Cellular: 917-***-**** Page 1 of 2

QUALITY DIRECTOR / OPERATIONS DIRECTOR

Integrate skill sets in an aggressive forward moving organization who desires to surpass the client expectations, through “Value-Add” offerings and partnering becomes a reality. A dynamic Quality Assurance / Supply-Line Logistics / Operations Director opportunity open to the definition of both the spoken & unspoken client requirements through the use of quantitative decisive tools and customer-centric team commitment. Achieve audit compliance to strict Global standards is part of the Quality & Operations toolbox as the commitment to a unified product/process is assured to our clients. Provide interactive leadership necessary to drive/motivate team members to design required scaling which consistently provides a continuous stream of process improvements for the client. Incorporate knowledge of Quantitative Analysis, Applied Business Statistics, Audit Compliance, B2B Logistics, Kaizen Events, Process Management, Six-Sigma Competency for Descriptive & Inferential Analysis, Technical Communications, Management & Motivational Skills, and Program Management techniques are the means to exceed the client’s expectations. AREAS OF EXPERTISE/CORE COMPETENCIES

QUALITY MANAGEMENT OPERATIONS AUDIT & COMPLIANCE

Applied Business Analytics

Six-Sigma Black Belt

DMAIC & DFSS (Kano Modelling)

Quantitative Analysis / GMP / SOP

Critical Path Methodology - Value Add

Core Customer Service Communications

Statistical Training / Root Cause / DOE

Enhance Manufacturing Processes

Project Management

B2B Integration Scheduling Logistics

Customer Satisfaction Enhancements

Supply Chain Management

Value Stream Mapping

Descriptive & Inferential Forecasting

Competitive / Client Survey Analysis

MS Office / Minitab / Business Suites

ISO 9001, 27001, 20000 / ITAR / EAR

CMMi for Services & Development

Program Management

Team Training Compliance

Statistical Modelling

Process Monitoring & Presentations

Regulatory & Reporting Compliance

Enterprise Compliance

EXPERIENCE

TATA Consultancy Services, Ohio Quality Manager/Director, Cincinnati GDC (SSBB) 12/2007 – 5/2016

Managed/achieved ISO Triple Audit Enterprise Certification compliance; achieving 2 noted Best Practices within TCS with compliance by example. Managed external client audits to ensure alignment for GDC Global compliance. Prepared/presented TCS NA Enterprise interests to achieve CMMi Level 5 (Optimized) Service & Development. Instructed TCS guidelines of iQMS principles and TBEM application.

Supervised customer team efforts and problem resolution through the use of descriptive tool management. Facilitated team efforts to determine the root cause of the client’s concerns through the use of tiered analysis determining exact client requirements as spoken and driving factors to ensure comprehensive requirement gathering. Use of analytical tools to drive completion of the requirement aggregation process, and the presentation of the result to stakeholders. Realize process/project pulse to ensure real-time compliance with project timeline

Coordinated group efforts to obtain expected results and deliver “Value-Add” to the derived output for detailed project plans and work assignments. Define overall milestones and delivery scheduled for each segment working toward determined goal. Coordinated with team to ensure minimized backlog management and process bottlenecks through the use of FMEA application with resolution/mitigation efforts

Served as Customer Liaison and consulted iQMS compliance for Cincinnati GDC through iQMS, Federal, State, and Local Regulatory Standards. Scheduled/managed center project & support group analysis involving client/regulatory Audits, PMRs, and process health verifications. Managed all audit findings to an efficient/effective closure resolution with permanent corrective actions monitored through KPI implementation. Quantitative methods used to drive consistently high CSS. Constructed/managed account inferential CSS models to proactively define client improvement opportunities to align with client expectations

Scheduled/Implemented/managed customer-centric project metrics. Managed ITAR/EAR initiatives and US Regulatory compliance aligned with development documentation for the specificity of the GDC while managing user requirements. Provided iQMS training and implementation with project mentoring for statistical data enhancements. GDC action item depository for Support Group efforts and process performance. Composed required US based Tailoring documents to isolate regulatory restrictions within US territories vs TCS Corporate

Member of Commercial Small Business Lending (SBL) team for the SBL initiative. Interfaced with strategic internal clients. Developed new process work flow construction for Business Credit Loans/Card flows vs. Line of Credit wrt new or existing Bank Clients. Created Business Requirement Document (BRD) for Portfolio Management & “Minimal Touch” Score Card selection analysis requirements. Created initial inferential process flow for Score Card introduction to current loan work flows. Developed introduction of the Customer Satisfaction Kano Model & metrics to isolate the key driving factors associated with the identification of external client “Delighters”.

Coordinated/reviewed Adaptiv Training materials (Release 1.3.1) to ensure collaboration between printed material and application screenshots. Interfaced with developer community to ensure project validation remained on schedule. Completed program management of user requirements and TCS efforts. Managed validation role requirements for user template vs. Adaptiv permissions. Electronic documents & Signature compliance wrt 21 CFR Part 11. Funding transferred to larger main project Michael R. Goede

Residence: 513-***-**** E-Mail: ******@***.*** Cellular: 917-***-**** Page 2 of 2

Aqua-Vita, Florida (Startup - NYS Remote) Director of Operations (SSBB) 11/2006 – 12/2007

Coordinated program management for NYS “Start-Up” business expansion. Design stages of linear & rotary bottling filling stations (Water) with multiple stages for injection molding through automated sorting/packaging process stations.

Assisted Marketing study implementation of “4 Ps” – Product, Price, Place, and Promotion of controlled variables, while providing influence of uncontrollable competitive variables, defining elastic & in-elastic differences. Implemented/managed DFSS analysis of customer demand cycles - Introduction/Growth/Maturity/Decline.

Led customer demand logistics & demographics assignment. Developed competitive product comparisons of variables purchase w.r.t CSS.

“Worth What Paid For” of “Price vs. Value” and “Value Add Competitive Alignment”. Negotiated secured client approvals to drive project efforts through readiness of performance assessments & checklists. Corning Life Sciences, New York Program & Quality Assurance Manager (SSBB) 9/2005 – 11/2006

Managed customer compliance, product release assurance, lab validation & GLPs, specification assurance, document control, GMP, ISO 9001:2000 & FDA regulatory compliance. Designed Change Control system and tracking capabilities for product “Form, Fit, & Function”. Developed/managed 8D Customer Compliance tool. Addressed clean-room, manufacturing, & customer specification issues. Developed Supplier Management algorithm to ensure incoming raw materials adhered to strict quality standards.

Designed/consulted Six-Sigma DMAIC algorithms to address emerging business needs while managing the client’s expectations. Performed risk assessments & business impacts to ensure client was aware of mitigation requirements, while consistently monitoring FDA process requirements associated with manufacturing disposable medical devices & plastic bio-storage containers.

Developed mathematical models to support goals & identified/saved product cost reduction opportunities >$120K. Designed data migration system to maximize information transforms from segmented sources. Sourced decision making-indices for real-time production applications. Bosch Security System, New York Product Quality Improvement Manager (SSBB) 4/2004 – 9/2005

Transformed Six-Sigma DMAIC & DFSS strategies throughout Bosch Security Systems with high profile product lines. Provided project support/instruction to Bosch ST Green Belt Population. Developed Six-Sigma DFSS primary infrastructure for ST wide implementation.

Implemented Global DFSS Repair Data project for 6 sites – reduced cost >$538K annually. Co-developer of inferential forecasting WRR PPM predictor tool, forecasting data analysis effectiveness for product. Supervised automation & objective product warranty rate trends Sears, New Jersey Consultant 9/2002 – 4/2004

Administered alignment to program tracking metrics for compliance to national retail requirements. Managed daily system averages vs. weekly standards to drive responsibility metric and monitor deficient areas for increased continuous improvement opportunities. AT&T, New Jersey (Telcordia Technologies) Senior Software Quality Assurance Manager 9/2000 – 9/2002

Developed/managed proactive MOP (Measure of Progress) Prediction Metrics model for SQA Center; ensuring direct product correlation with 11 status indicators supporting performance metrics. Optimized efficiency of SQA metrics performance; creation of new inferential guidelines. Coordinated/managed functional development/testing interface, between organizations, ensuring successful software release symmetry.

Supervised “Business Model” linkage to SQA MOPs, providing connection of the “golden tread” across indicators utilized by the SQA organization. Coordinated the strength of Telcordia’s SQA Industry Presence at National Software Quality Conferences. Identified metrics to initiate a Benchmark study of the SQA Products/Services against “Best-in-Class” industry leaders for future customer requirements. ADDITIONAL EXPERIENCES

AT&T, New Jersey (Lucent Technologies) AMPS/PCS ISO Quality Manager AT&T Submarine Systems, Inc., New Jersey (AT&T) Senior Technical Staff Member AT&T, New York (Lucent Technologies) Quality & Customer Satisfaction Manager EDUCATION

Six-Sigma Black Belt, Villanova University Program - Certificate M.S. Quality Systems Management, The National Graduate School, MA MBA (2nd Concentration), Quantitative Analysis, Fairleigh Dickinson University, NJ M.A. English/Technical Communications, Fairleigh Dickinson University, NJ Technical Writing Certificate, Fairleigh Dickinson University, NJ MBA Industrial Management, Fairleigh Dickinson University, NJ B.S. Electrical Engineering Technology (Acoustics), Fairleigh Dickinson University, NJ

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