SUMMARY:

LEAN MANUFACTURING QUALITY PROJECT MANAGEMENT Highly accomplished professional with strong global background and in - depth experience in operations, quality, project management, and business building in multiple industries. Launched many automotive and consumer products from concept to production successfully. Results-oriented leader, with proven success in assessing manufacturing capacity, quality capabilities, QS audits, root cause analysis & corrective actions, continuous process improvement, supplier development, global sourcing and new product/process development.

CORE COMPETENCIES:

• Continuous Improvement Management
• Customer Liaison & Satisfaction
• Root Cause Analysis & Corrective Action
• Quality Control, SPC, TQM, GD &T
• Value Stream Mapping
• New Product/Process Implementation (NPI)
• Six Sigma, JIT, 5 S, Kaizen
• GDP and GLP
• APQP, PPAP, FMEA, Layered Process Audits
• Plant Layout & Setup, Product launch, TPM
• QS-9000 / ISO 9000 & TS16949
• Supplier Selection and Development
• Equipment Selection and Installation
• Team Building and Leadership
• Measurement System Analysis - Gauge R&R
• Lean Manufacturing

COMPUTER SKILLS:

PowerPoint, Word, Mini Tab, Excel, MS Access Microsoft Project, Visio, Math lab, Simulink

PROFESSIONAL EXPERIENCE:

Confidential, Joplin, MO

Senior Manufacturing/Quality Engineer

Responsibilities:

• Actively improve and drive process, productivity and quality improvements through measurements, detailed analysis and sustaining improvements with process control mthods in accordance with GMP, ISO and AS - 9100 quality system methods
• Function as team leader in problem solving and manufacturing process improvements by utilizing engineering or scientific discipline, statistical analysis tools such as SPC and lean six sigma to drive stability and overall systematic process improvements
• Responsible for design and development of automated equipment, design for manufacturability on new projects for major ramp up in production in the stage gate process
• Work with manufacturing and engineering department to developed processes with “built in quality” and to qualify and validate new equipments, processes and procedures in IQ, OQ &PQ stages
• Developed detailed work instructions that involved multiplr steps of complex equipment and maintaining documentation of same - GDP
• Participated and lead Corrective Action Board meeting and resolution of problem reports with supervisors of Quality, Engineering and Production. Make recommendation for equipment and inspection improvements and utilize six sigma and 5S methods for improvements in facility lay out and process flow
• Maintained projects driving continuous improvements of process improvements, EHS and other improvements projects through the use of SPC data and factory metrics. Quality projects were strategacially design to follow EaglePicher Quality Roadmaps

Confidential, Elyria, Ohio

SENIOR SUPPLIER QUALITY DEVELOPMENT ENGINEER - PROJECT LEADER

Responsibilities:

• Lead improvements & development with Confidential suppliers (die casting, standartd parts, rubber, plastic, glass, stamping machining and forging - SMF).
• Supported supplier transition teams when tools are being move between suppliers and act as liason between supplier groups, buyers, plant quality and engineering.
• Acting as mediator between suppliers and plant quality when problem arise (Dispute Process) in the DMI/PSI Process - “Enhanced Design & Manufacturing Integrity Reviews”and “Pass thru and Special Characteristics Flow-Down & Integrity Reviews”.
• Conducted supplier audits, evaluated suppliers, conduct on-site Production Part Approval Process (PPAP) as requested by using plant, and performed supplier improvements and development projects. Reviewed and approved for flowdown of the Confidential DFMEA into the supplier’s APQP documents.
• Maintained Vendor master information status in the Quality Management System Status Matrix (QMSS) to include supplier release and classification status.
• Supported and lead Supplier Quality & Development (SQD) portion of Supplier Base Integretion Team (SBIT) and Supplier Continuous Improvements (SCI) meetings to drive supplier performance improvements (SQDCME).
• As the Supplier Quality Development Engineer, I lead supplier performance evaluation and supplier quality development activities as well as established and maintained local supplier quality related procedures and practices, based on global procedures.
• Experienced in a supply chain or quality roles working with supplier quality issues, knowledge of ISO standards and ability to multi-task. Experience in a high mix/low volume manufacturing environment, knowledge of electro-mechanical components and mechanical assemblies.
• Working knowledge of ISO 9000:2000 and TS 16949 standards required, Sound knowledge of Automotive Industry Action Group (IAIG) modules including PPAP, Statistical Process Control (SPC), Measurement System Analysis (MSA), Failure Mode & Effect Analysis (FMEA), Advance Quality Planning & Control Plan (APQP) was required and demonstrated for the effective execution of the assignment.

Confidential, Miami Lakes, Florida

SENIOR SUPPLIER QUALITY ENGINEER

Responsibilities:

• As the lead SQE between the company’s QA Organization and its suppliers, ensured appropriate support is provided for quality assurance activities, supporting product development and commercialization goals and objectives.
• Managed the daily QA/QC activities required to support manufacturing production area including coordination of inspection/testing in Receiving Area (RI) - Thorough knowledge of compliance, ISO 13485, 21 CFR Part 820 & FDA Regulations
• Utilizes existing approved suppliers on the ASL whenever possible for components, finished devices or services to be obtained by Confidential .
• Intiiated and submit ASL change form FM01120 for supplier changes and supplier risk determination form FM01048
• Integrated proven and sound quality system/practices into the Supplier Chain Management Program, provided guidance in preparation of technical assessment of technology and ensured that corrective measures meet acceptable reliability standards
• Managed and maintainAapproved Supplier Program, Lead supplier’s Qualification and component verification activities and ensured compliance to all customers, QSR, cGMP, ISO, and Medical Device Directive requirements
• Integrated Quality System into supplier chain management programs, provided guidance in preparation of technical assessment of technology and ensured proper documentation of complaint evaluations
• Is the issue supplier related, ie The failure appears to be caused by asupplier, 2.
• Does a control point exist on the inspection plan ( IP) for the product characteristic, 3. Is there an open SCAR for this issue, 4. Is sort/re-inspection, or rework, or other disposition required before final disposition and 5. Final REVIEW and FINAL DISPOSITION and APPROVALS

Confidential, Warsaw, Indiana

SENIOR TECHNICAL LEAD - SUPPLIER QUALITY ENGINEER

Responsibilities:

• Assuring product conformed to established requirements and standards through appropriate test activities, audits and inspections (RI).
• Interacted cross functionally with many departments, suppliers and subject matter experts within and outside the company to fulfill quality requirements/goals.
• Served as the primary technical liaison between suppliers, Purchasing, Supplier Quality Engineering and the NPD project teams.
• Secondary processing included: Bar turning, drilling, milling, blasting, passivation, autoclaving, CNC grinding, manual polishing/assembly, EDM and Anodizing.
• Depending on the joint being manufactured, secondary processes are selected and part routed accordingly.
• Lead and participated in Production and Process Control activities for development, implementation and improvements of manufacturing quality plans, inspection and testing plans, risk analysis/mitigation per the QMS and validation protocals for new and modified products and processes.
• Manage process validation and process improvements activities, design and procure production gages, train, guide and mentor new quality engineers.
• Participated in resource planning and attended project meetings to communicate and set project time lines to meet company goals and objectives for on timr delivery.
• This position has the responsibility and authority to assure materials supplied for attune products are of high quality and reliability.
• Provided Quality engineering support to suppliers including auditing/assessments, inspection technical support, verification/validation activities, CAPA and change management.
• Drive thorough root cause analysis and corrective actions relating to supplied material issues in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Responsibilities include communicating and leading technical objectives between DePUY and material suppliers.
• This includes leading activities such as: supplier qualification, supplier development, facilitating improvements, material evaluation and qualification/validation, disposition of non-conforming material/corrective action, support of commodity and new product development teams.
• As the Sr. SQE helps set strategic direction for the quality organization and is responsible for designing and implementing methods and procedures for inspecting, testing, and evaluating purchased material. Applies statistical methods to assess conformity of materials and analyzes quality indicators from suppliers for use in business decisions.
• Experience/knowledge with machining manufacturing processes and injection molding, blueprint literacy including GD&T and travel were required of the assignment.
• Evaluated supplier test protocals and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Provided input to design and manufacturing documentation including material specifications, drawings, inspection procedures and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Assisted with the analysis and resolution of design or manufacturing material problems as these arise, contributed to material design input requirements from experience with previously reported problems, attune products, competitive devices and /or other similar products.

Confidential, Cleveland, Ohio

SENIOR (Sr) SUPPLIER QUALITY ENGINEER

Responsibilities:

• Responsible for the quality performance of an identified group of suppliers defined my manufacturing value stream and/or material commodity.
• Worked in an ISO 13485, 21 CFR 820, IEC 60601-1 and IPC 610 regulated environment, produced components and equipment, assembled parts and sub-assemblies for Confidential, a leading global provider of medical devices (Image Scanners).
• Partnered closely with value stream buyers/planners to ensure supplier quality issues are managed in a timely manner in order to minimize the impact to customer delivery and strategic sourcing initiatives that drives commodity strategies as well as engineering and regulatory to manage supplier change request (SCR) and deviations.
• Responsible for evaluating all quality concerns associated with purchase components, sub-assemblies, finished devices and/or services for my assigned group of suppliers
• Assure timely responses regarding product complaints and took ownership of driving root cause corrective actions at the suppliers through supplier corrective and preventative action (CAPA). Improved supplier quality performance through the use of process expertise, problem solving tools and SPC tools. Lead Green Belt activities and promote the use of statistical process control to prevent quality issues, Process Validation (IQ/OQ/PQ) and & FAI
• Ensured the planning, organization & coordination of corrective action implementation and proper level of control is in place at suppliers that is commensurate with product risk level (W, X,Y, & Z)
• Delivered results as measured by key metrics- such as incoming lot acceptance rate, supplier yields, and supplier caused complaints & SCAR effectiveness and timeliness. Disposition incoming receiving non-conformances that are supplier caused. Investigated and reported out on supplier corrective action effectiveness and timeliness
• Engaged in Product Specification Verification (PSV) of inventory needed for production and accountable for preparing, reviewing and approving PSV packages and Supplier Parts Qualification (SPQ) packages (PPAP)
• Verification activities included analysis of of Compliance, RoHS, Material Certs, Inspection Data (FAI) and Special Process Requirements review and evaluation. Contacted suppliers to acquire required documentation to support parts approval process. Documented, summarized, reviewed and presented data to customer to support part approval.
• Worked closely with purchasing (buyers) to communicate PSV and SPQ requirements to suppliers. Monitored quality performance of suppliers’ and resolved parts manufacturing issues/concerns with Design Engineers (DE), Product Quality Engineer (PQE) & tracked /resolved ECO’s concerns
• Trained in Confidential Corrective Actions Preventative Actions - CAPA procedures to handle non-conformances as a result of suppliers and manufacturing. Facilitated investigations, generated reports and report out to management on issues/concerns
• Liaison with Receiving Inspection (RI) to get parts to pick able status for production build and assembly, i.e.
• Managed supplier s (PSV & SPQ) and dock to stock program for my assign group of commodity suppliers/parts
• Collaborated with Sourcing and Procurement on strategic initiatives that aligned with commodity strategies, product family and work streams
• Developed plan to validate CT/AMI/PET scanners, product and process design by actively participating on teams formed to improved performance, reliability and overall quality.
• These include design reviews, Mock-up reviews, SDT’S, PDT’S and process review.
• Coordinated validation for buy parts, ROHS, FIA and material certs as a member of the purchasing team.

Confidential, Detroit, Michigan

Supplier Technical Assistance/ Industrial Engineering Manufacturing

Responsibilities:

• During a new launch of Confidential vehicle Instrumental Panel assembly and on highly compressed time tables, I was responsible for coordinating, reviewing, tracking and reporting of level 3 PPAP for over 150 components.
• Assignment required interaction with nearly 100 external suppliers over a period of weeks.
• Careful communication and detail data base entries with internal program champions and PPAP review team’s member’s daily, as well as verbal and written standard reporting to internal executive team on a daily/weekly basis. Confidential motor company and its suppliers work together to deliver a quality part, produced on- time, that meets all Confidential engineering requirements to drive flawless execution in launching and delivering products that surpass customers’ expectations in an environment of trust, integrity and accuracy above all else in Production Part Approval Process.
• Confirmed that customer engineering design records and specification requirements are properly understood by the supplier, and that all production streams have the potential to produce products consistently meeting requirements during the actual production run at the quoted production rate
• Phased PPAP provided Confidential & the suppliers with an improved understanding of supplier manufacturing process and parts readiness - audited, tools, machinery, manpower and other process requirements for process sign- off
• Verified that the supplier’s production system can support the daily production volumes declared by the customer
• Provided programs teams with early and additional data to measure and forecast program/product readiness for respective vehicle lines
• Reviewed and either approved or reject the PPAP submission warrants in the Vehicle Parts Progress Database (VPP)
• Confirmed that all production in-puts requirements are available and understood, and can support a limited production run
• Evaluated and verified PPAP warrants from the suppliers to declare that inspection and test on production parts shows conformance to customer specification

Confidential, Gary, Indiana

Continuous Improvement/ Industrial Engineering Manufacturing

Responsibilities:

• Quality audit assessment with fundamental understanding of quality philosophies and principles applied to validation
• Proficient with current Good Manufacturing Practices (cGMP),current Good Laboratory Practices (cGLP), ISO 9000
• Assure that timely responses regarding product complaints are provided to the manufacturing floor and monitored/controlled
• Ensure the planning, organization & coordination of the molding and assembly operation are executed in the most effective and efficient manner while operating within the safety & regulatory guidelines and policies set forth by Smiths medical to drive the business forward
• Optimize work center efficiencies thru Lean Manufacturing Principles (value stream mapping - current & future state, error proofing, JIT, TPM, small group activities and 6 sigma). Reviewed daily KPIs related to production, inventory accuracy & labor efficiency
• Interacted with all departments and communicated the needs and requirements of the manufacturing department with minimal supervision
• Developed, reviewed, modified and enforced department procedures to comply with company policies - Quality, Regulatory, Good Manufacturing Practices (GMP) for medical devices & 21 CFR Part 820 Quality System Regulations
• Assignment was partially responsible for the assurance of company operations to all applicable laws, regulations and standards, good business practices and company documented procedures - including but not limited to FDA, quality systems regulation, ISO 13485, ISO 1401, government occupational health & environmental regulations and statues