GAY LEE ALVIS

**** ******** ****** *************** ** 22911

H 434-***-**** aculvt@r.postjobfree.com C 434-***-****

QUALITY MANAGEMENT PROFESSIONAL

PROFILE

Highly accomplished and experienced quality management professional with a record of achievement guiding all aspects of quality management in multiple manufacturing industries including Plastics – PET, Automotive, Aerospace, Marine Propulsion, Packaging (Food grade and Pharmaceutical Class II & III), Medical Device (Class I,II, & III) Consumer Products. Always improved organizational quality, effectiveness, and efficiency through a personal contribution that aligns the business processes and technical infrastructure to realize cost savings, accelerated performance, and a strategic flexibility that provide a competitive advantage for the organization. Kanban, Gemba Walks, 5S, Lean training and experience.

Expertise in ISO 9001:2008, & 2015 development and implementation with extensive scope of responsibility and a proven track record of delivering optimal results that continually improves key process indicators. Certified Global Exemplar Lead Auditor for ISO 9001:2008 & 2015– AQS, Internal Auditor for 13485 experience.

Strong ability to interact at all levels of the organization to drive a continuous improvement culture, providing training, support, and oversight.

Exceptional leadership skills utilized in managing teams of up to fifteen Quality professionals.

CORE COMPETENCIES

American Society for Quality (ASQ) Quality Auditor • Supplier Quality Engineer • Performance Optimization

American Society for Quality (ASQ) Certified Quality Engineer • ISO 9001:2008 & 2015 Standards

American Society for Quality (ASQ) Certified Quality Manager / Organizational Excellence (CQM/OE)

Certified Food Defense Coordinator • Kaizen • Lean Manufacturing • Poke-Yokes

8D Problem Solving • Quality Improvement Teams (QIT) • APQP• PPAP Submissions • Six Sigma

Quality Management System Development • Strategic Quality Planning

DMAIC• Quality Management System Implementation• cGMPs• 21CFR810

Performance Based Continuous Improvement • 13485 Standard compliance

Hazard Analysis Critical Control Point (HACCP) • CAPA•GDTC• Corrective Action Requests (SCAR & CARs) • Advanced Product Quality Planning (APQP)) • 5S Instruction

PROFESSIONAL EXPERIENCE

Hollister Incorporated Stuarts Draft, VA May 2013 – February 2016

Senior Quality Engineer, Contract

Plant manufacturing, New Product Development & Tech Services Development Quality Engineer, Plant overflow Quality Engineer Support. Work has been in the BIM (injection molding) area, Mix area, and various protocols run throughout the plant including, Nonwoven, Faustel, Tape Team, Urostomy and 2 Piece Pouch. Execution of process capability studies, development of Feasibility, Validation, DOEs, IQ, OQ, and PQ and Double Blind Studies protocols, execution of protocols, data analysis on various studies, process improvement studies, document investigations, assisting Japan task force team in new release liners by studying air bubble reductions (leading a mix team). Data analysis on protocol evaluation, Support for plan quality engineers on work overflow, Supplier teams, protocol development of equipment moves, execution and other duties as necessary. Reduced air bubbles, foam, out defective vacuum batches from 50% to 2 of 444 batches increasing throughput and reducing defects and enhancing customer satisfaction for Japan customers

Contract ended after all projects completed and 2016 Budget was finalized.

Continental Corporation Culpeper, VA April 2012 – May 2013

Quality Engineer – Weekend Supervisor, Service Quality Engineer and Weekend Supervisor for Service Production Lines with full responsibility for quality and production shipping metrics – service value stream. Conduct internal audits for all business

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processes. Review supplier ratings, perform Supplier Corrective Action Request development, supplier PPAP requests, reviews, APQP and complete other supplier quality measurements. Approve, Write and Develop Standard Operating Procedures (SOP) and WES (Work Element Instructions) for TS manual, as well as work with various teams to ensure new production lines were validated, did production PPAPs of all service production lines for startup in Culpeper. Wrote packaging instructions for operators, audited outgoing shipments, reviewed these weekly in Safe-launch audit reports, trained operators and leads on new processes including the new production lines for brake production, webbing, peening, caliper building, etc. Direct Contact with Ford, GM, Chrysler for PPAP submissions, 8D review and submissions, and other duties as necessary. Performed Verification and Validation protocols, as required. Performed hourly performance review submissions to HR, on call 7 days a week for line problem resolution, including drawing review, specification review, and SAP correction as necessary. Daily MRB review and analysis. Developed Value Stream Maps, Process Maps and Work Instructions.

Downsized after production lines were accepted by Ford, Chevrolet, Toyota etc. Trained 3 personnel over different production lines in Continental to perform ongoing duties.

MicroAire Surgical Instruments Charlottesville, VA May 2011 – April 2012

Quality Engineer Quality Engineer and Internal Auditor (Internal and External) for Power motors and instruments (pneumatic and electrical) manufacturer with full responsibility for Quality for operational value stream. Conduct internal audits (part of the internal auditing team monthly) for all business processes. Review supplier ratings, perform Supplier Corrective Action Request development, and complete other supplier quality measurements. Approve write and develop Standard Operating Procedures (SOP) for 13485 manual, as well as work with various teams to develop New Product Development. Audited and worked with suppliers to reduce receiving quality issues, reducing CARs, Lead Pneumatic Motor team which increased First Time Yields from 45% to between 97 to 100%, and reduced Warranty Repair % rate from 68% to 29%. Performed Verification and Validation protocols, wrote protocols, performed IQ, OQ, PQ on operational instruments on value stream, and approved verification validation protocols for all key instruments in cells for manufacturing prior and after the move to the new facility. Wrote SRS (Software Reliability Protocols) for new product development, developed tests for circuit boards on RI, NPD, etc. Other duties performed as necessary. Developed Value Stream Maps, Process Maps and Work Instructions.

Trained Operators on Work Instruction

Followed DMAIC to increase FTY and reduce Scrap Rate from $2000 per mo. to $200 per month for power stream.

Lead Scrap Team, Developed Weekly Scrap Report and Scrap Dashboard for entire Organization.

Developed FTA, (Fault Tree Analysis, Risk Analysis) of NPD

Downsized after all California production lines were in production, apqp duties complete, ISO audit performed and production ongoing satisfactorily.

StarPet Inc. Asheboro, NC July 2008 – Feb 2011

Quality Auditor / Quality Engineer

Quality Auditor (Internal and External) and Quality Engineer for Plastics / PET Resin manufacturer with full responsibility for managing ISO development and audit program for the organization (internally and external). Conduct audits of business processes, including laboratory processes. Review supplier ratings, perform Supplier Corrective Action Request development, and complete other supplier quality measurements. Approve Standard Operating Procedures (SOP) for ISO 9001:2008 Standard (compliant with AIBI, ISO 22000, pharmaceutical class III resins and toy grade resin), as well as work with various teams to complete work instructions and other procedures. Developed and wrote QSM and QSOPs for the Quality Department (GLPs, cGMPs). HACCP coordinator. External Auditor for all suppliers. Developed and submitted ANDA, Annual Reviews and all amendments for the DMF (registered class III with the FDA pharmaceutical resins). Customer contact for audits, carbon footprint development, etc. Trained all associates on ISO awareness, cGMPs, etc. Over internal calibration, repeatability & reliability studies, process capability studies and purchasing certified lab equipment, capability studies and automated laboratory equipment to enable minimized time lapse between testing, results, COA development, and portals for production for better analysis and

capability enhancement. Improved capabilities (from previous average around .8 to greater than 1.3 for blends. Performed carbon foot print studies and reduction improvements for proposed carbon tax requirements.

Certified Food Defense Coordinator and primary contact for quality from governmental and other entities including the Food and Drug Administration (FDA) and foreign countries, s.a. Canada, Mexico, England, Japan, etc..

Maintained quality records, forms, and documentation in accordance with Quality Assurance Systems and Processes.

Downsized after Starpet was bought out by Indorama and new management put the ISO program on hold. Plant Manager took over all Quality Management duties.

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D&D Enterprises Randleman, NC September 2006 – January 2008

Quality Manager Managed production inspection and Total Quality Management (TQM) systems for supplier to aerospace, marine propulsion, consumer products, and defense industries, providing training and development to employees for increased quality and productivity. Overall aspects of Quality, such as control plans, internal calibration, external calibration and inspection. Developed, and trained others to develop, Statistical Process Controls (SPC) to decrease defects and increase efficiency, as well as instructed employees on 5S. Facilitated Customer Problem Resolution through 8D development. Managed customer surveys and assessments, ensuring appropriate follow up with suppliers on quality issues.

Material Review Board (MRB) Team Leader, driving prompt determinations of Nonconforming Material Review, Status, and Disposition.

Developed ISO Manual compliant with AS9100 and 9001; established First Article Inspection Reports. (Including CMM inspection, Mag particle inspection, Rockwell hardness tests, Comparators, etc.)

Position eliminated after D&D lost BAE contract due to being underbid on pricing.

Quality Manager, Rymac Enterprises (a division of Q3JMC Inc.) October 2004 - June 2005

Provided strategic direction to production lines, including automotive injection production (Tier I supplier to Volvo and others). Documented, developed, and audited procedures, practices for compliance, and ISO 9001:2008 from previous standard registration. Created and implemented systems for trending production and performance quality levels. Responded to customer concerns by writing corrective actions, interacting with customers, and working with team to resolve issues. Overall Supplier Issues, Auditing, SCARs, Customer and Supplier main interface, contact. Supplier development, MRB. Established, implemented, and maintained Quality Management System to include corrective action and documentation processes. Updated quality manual, functions, procedures, and processes as required. Utilizing industry best practices identified and prioritized quality-improvement opportunities and proposed quality-improvement measures. Trained Quality Department team members in quality methods and metrics. Established and implemented training programs necessary to ensure predictable execution and continuous improvement.

Left position when my mother died, had to handle estate issues.

PREVIOUS PROFESSIONAL EXPERIENCE

A.O. Smith Mebane, NC May 2000 – June 2001

Quality Engineer

Production moved to Mexico, eliminating Quality Engineering needs in Mebane.

B.T.R. Reidsville, NC April 1999 - April 2000

Quality Engineer - BMW and Ford Accounts, Achieved Ford Q1 Award

Company bought facility, new owners downsized all salary employees and replaced them with their own personnel.

Note: Substitute teacher for the Guilford County School district during periods of Job Search.

References sent on request.

EDUCATION

Bachelor of Arts, Physics Miami University, Oxford, OH, Graduate studies towards an MME at Jacksonville University, Jacksonville. Florida

CERTIFICATIONS

Certified Quality Engineer; (CQE) - American Society for Quality

Certified Quality Auditor; (CQA) - American Society for Quality

Certified Six Sigma Green Belt, (CSSGB) - American Society for Quality

AQS – Global Exemplar Lead Certified Quality Auditor ISO 9001:2008 & 2015

Certified Math, Physics and Chemistry HS & Middle School Teacher-FL,

Certified Quality Manager / Organizational Excellence (CQM/OE) – American Society for Quality

Certified Food Defense Coordinator – AIBI, GenEdge Lean 101 – Principles of Lean Manufacturing

ASSOCIATIONS: Member of ASQ, ASTM, ACS, SPE, SARA and Miami Alumni Association

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