Quality Engineer Manager

GAY LEE ALVIS

**** ******** ******* ******, ***************, MANAGEMENT VA 434-***-**** PROFESSIONAL home phone *********@*****.*** Dynamic Quality Management Professional with deep-rooted experience and a proven track record of success and dedication to executing continuous improvements and modifications 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. An expert with invaluable knowledge of managing projects, resources and systems in an efficient and effective manner. Keen ability to quickly problem-solve issues and apply an effective solution. Highly focused and adept at consistently employing best business practices to improve the overall performance, and simultaneously reducing costs. A valued leader and contributor who has the ability to build and maintain positive relationships internally and externally, and work successfully as a team member as well as independently. Seeking a challenging position with a forward-thinking organization. CORE COMPETENCIES

ASQ Certified Quality Auditor

Experienced Supplier Quality Engineer

ASQ Certified Quality Engineer;

ISO 9001:2008 & 2015 Global Exemplar Certified Lead ISO 9001:2015 Auditor

Certified Food Defense Coordinator (AIB International), Certified Advanced SQF Practioner (SQF)

Kaizen, Lean Manufacturing Poke-Yokes

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

Quality Management System Development

Strategic Quality Planning

Canada, Mexico, and various countries point of contact, registration development

DMAIC Quality Management System Implementation

cGMPs, 21CFR810, AS9100:2015, FAIRs

Performance Based Continuous Improvement

13485 Standard Compliance

Hazard Analysis Critical Control Point (HACCP)

CAPA, GDT,SPC Corrective Action Requests (SCAR & CARs)

Advanced Product Quality Planning (APQP)

5S Instruction

ASQ Certified Six Sigma Green Belt

FDA point of contact, ANDA and trademark registration

ASQ Certified Quality Manager / Organizational

Excellence (CMQ/OE)

Masco Cabinetry PROFESSIONAL EXPERIENCE May 2018 – Oct 2018 Quality Manager, Culpeper VA

Over all aspects of Quality Compliance, (with corporate standards and ASCA American Association of Cabinetry), internal and external audits, Quality Manual compliance, production, color standards, incoming materials, Nonconforming Material Review Boards, calibration, training of inspectors – over 15 personnel direct reports. Trained personnel on new product development, developed control plans, initial product reviews, working with NPD and suppliers along with Customer Service. Capa development, 8D resolution and Customer complaint resolution. Corporate reporting on KPS, SPC, Scrap control, (reduction); overall quality improvement including CIP – Continual Improvement initiatives. Kaizen blitzes, 5S reporting, joint teams with suppliers on color improvement, L, A, and B monitoring and improvement of cPKs. Downsized when Company restructured with Plant Manager being over both Mt. Jackson facility and Culpeper, with 2019 budget changes requiring Continual Improvement Manager, Verify Global and – Plant VTR; Manager taking on Quality Manager duties. March 2017 – Jan 2018 Contract Quality Engineer – Aerojet Rocketdyne, Culpeper VA Responsible for Qualification FAI (First Article AS9100:2015) of new production lines for SM3 IB and IIA process for Aerojet Rocketdyne facility.

(Production lines moved from California to Culpeper VA). Development, implementation and execution, including direct contact with MDA and customers (Raytheon) submission, review and approval. Responsibilities also included for NC write ups, CAR status reports, CAR development and submissions, Quality Engineering duties on production lines for assistance whenever needed such as FOD, FETA, process auditing, etc. Trained in AS9100 – 2015 version, DOD regulations and various areas of safety, government ethics, and quality processes. Matrix development for tracing status of implementation of processes, project status, CIP

– Continual improvement processes on FAI process and SOWs, training, and other duties as necessary. Completed project, all lines passed MDA audits and ISO 9001:2015 audit. Finished production lines acceptance ahead of schedule by two months.

Read/Translate Blue Prints

Test Planning & Tracking

Project Analysis & Metrics

Risk Analysis

Defect Management

Project Management

Performance Management

Staff Training, Coaching &

Mentoring

Conflict Resolution

Communication (Internal/External)

Customer Satisfaction

Strategic Planning

Executive Communications

Negotiation Skills

Gay Lee Alvis – resume page 2

Phoenix Packaging, Dublin VA May 2016 – Feb 2017

Quality Manager; Quality Compliance Manager

Overall Quality Systems Responsibilities including managing production inspection, 20 lab personnel, over quality systems supplying food customers such as Danone, Keurig and General Mills. Direct Customer contact, in addition to working with R&D and various other issues relating to quality throughout the company. Providing training, development of employees for increased quality and productivity. Taught cGMPs, Haccp, Harpc, Food Defense, Risk Management and various other areas as necessary. Material Review Board Team Leader, driving prompt determination of Nonconforming Material Review, Status & Disposition. Took lateral move to Quality Compliance Manager in September after SQF practioner left. Managed Quality Systems development for SQF, IMS, FDA compliance, backup Quality Manager while acting Quality Manager out at customer locations, vacations, and various other reasons, duties. On call 24-7. Lead Crisis Management team through drills, developing food defense audits, systems and manual including Food Quality Plan and Audit Plan. Lead Audit team (internal and external) and certification team for Manual development, systems compliance and enabled facility to achieve level 3 certification of SQF in January (Cert ID registrar). Downsized after 2017 budget review reduction in customer sales and company restructuring. HOLLISTER, INC., Stuarts Draft, VA April - 13 – Feb. 2016 Senior Quality Engineer

Apply leadership and expertise in contract plant manufacturing, new product development and technical services development quality engineer, plant overflow quality engineer support.

Provide support in the BIM (injection molding) area, Mix area, and multiple protocols throughout the plant. Including various protocols on Nonwoven, Faustel, Tape Team, Urostomy and 2 Piece Pouch.

Executed the 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).

Facilitate data analysis on protocol evaluation, support quality engineers on work overflow, Supplier teams, protocol development of equipment moves, Validation and Verification studies along with additional duties as assigned.

F tests, T statistics, dual blind sampling testing for NPD along with various other studies required for NPD team and FDA submission.

Quality Engineer floater, filling in for Quality Engineers while on vacation, traveling, etc. and other duties as required.

Successfully reduced air bubbles, foam, defective vacuum batches from 50% to 2% out of 444 batches, resulting in increased throughput and reduced defects and enhancing customer satisfaction for Japan customers.

Contract ended after all projects were completed and 2016 budget was revised for Hollister CONTINENTAL CORP., Culpeper, VA April 2012 – May 2013 Quality Engineer Weekend Supervisor, Service Quality Engineer, Weekend Supervisor for Service Production Line

Led in quality and production shipping metrics service value stream and conducting internal audits and business processes.

Examined supplier ratings, performed Supplier Corrective Action Request development, supplier PPAP requests, reviews, APQP and completed other supplier quality measurements.

Developed, wrote and approved Standard Operating Procedures (SOPs) and Work Element Instructions (WES) for TS manual, in addition to collaborating with various teams ensuring the validation of new production lines and conducted production PPAPs of all service production lines for startup in Culpeper.

Developed and documented packaging instructions for operators, audited outgoing shipments, conducted weekly review of Safe-launch audit reports, trained operators and leads on new processes, which included the new production lines for brake production, webbing, peening, caliper building, etc.

Direct Customer Contact, Problem Resolution with big 3, Toyota, etc.

Weekend Supervisor for all production lines in Service area, including 20 personnel, time sheets, evaluations, etc.

Downsized after ppaps were accepted and lines were in production for Ford, Chevrolet, Toyota, etc. Trained 3 people to take over my responsibilities that were over different production lines in the facility. MICROAIRE SURGICAL INSTRUMENTS, Charlottesville, VA May 2011 - April 2012 Quality Engineer and Internal Auditor (Internal/External)

Maintained full charge and responsibility for Quality of operational stream of a power motors and instruments (pneumatic and electrical) manufacturer.

Expertly conducted internal audits (as part of the monthly internal auditing team) for all business processes.

Analyzed supplier ratings, performed supplier Corrective Action Request development, and completed other supplier quality measurements.

Developed, wrote and approved Standard Operating Procedures (SOPs) for 13485 manual, and collaborated 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 percentage rate from 68% to 29%.

Effectively reduced Scrap Rate from $2,000 to $200 per month for power stream.

Downsized after transfers from California production line were complete, lines in production and all APQP, ISO audits done and lines in good production order in new facility for MicroAire. Gay Lee Alvis – resume page 3

STARPET, INC., Asheboro, NC July 2008 – Feb 2011

Quality Auditor (Internal/External), Quality Engineer, for Plastics

Provided leadership and management of ISO development and audit program for a PET Resin manufacturer (internally and external).

Conducted audits of business processes, which included laboratory processes, and suppliers.

Reviewed supplier ratings, performed supplier Corrective Action Request development, and completed other supplier quality measurements.

Approved all Standard Operating Procedures (SOPs) 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.

Created and wrote QSM and QSOPs for the Quality Department (GLPs, cGMPs).

Developed and submitted ANDA to FDA, Annual Reviews and all amendment for the DMF (registered class II with the FDA pharmaceutical).

Conducted joint Customer audits, customer direct contact for audits, problem resolution.

Over all calibration internal and external, repeatability & reliability studies, process capability studies.

Automated laboratory equipment enabling minimized time lapse between testing, results, COA development and portals for production analysis and capability enhancement

Improved capabilities to greater than 1.3 for blends

Performed carbon foot print studies and reduction improvements for proposed carbon tax requirements.

Responsible and over all microbiological testing for product and plant processes, i.e. water.

Food Defense Coordinator, working along with suppliers and pest control ensuring FDA food grade – AIBI requirements for customers i.e. Nestle, and others.

Trained all personnel on ISO awareness, cGMPs, etc. Other duties as required, interim Quality Manager since the Quality Manager left the company in 2009.

On call 24-7; fill in for lab technicians and lab supervisor when necessary.

Downsized after Starpet was bought out by Indorama and new management not interested in ISO program, my position was not deemed necessary and plant manager took over Quality Manager position. D&D Enterprises, Randleman, NC May 2006 – March 2008 Quality Manager, Total Quality Manager

Overall Quality Systems, Development and execution thereof including, production inspection, TWM – Total Quality Management systems for supplier to aerospace, marine propulsion, consumer products and defense industries (DOD) providing training and development to employees for increased quality and productivity. Control plans, internal calibration, external calibration, Customer supplier teams, Statistical Process Controls SPC to decreased defects and increase efficiency, as well as instructed employees on 5S, Lean. Facilitated Customer Problem Resolution through CAPA – 8D development process. Managed customer surveys and assessments, Lead Supplier Audits, ensuring appropriate follow up with suppliers on quality issues. Lead Material Review Board MRB Team Leader, driving prompt determinations of Nonconforming Material Review, Status and Disposition. Developed Quality ISO Compliant Manual, also compliant with AS9100. Established FAI – First Article Inspection reports, including CMM inspection, Mag particle inspection, Rockwell hardness tests, Comparators, etc. PROFESSIONAL EXPERIENCE / AFILIATIONS

Graduate Coursework towards, MME, Jacksonville University, Jacksonville, FL

Bachelor of Arts, Physics, Miami University, Oxford, OH

Certified Teacher, High School and Middle School Math, Physics and Chemistry, State of Florida

Member, ASQ, ASTM, ACS, SPE, SARA

Member, Miami Alumni Association

References furnished upon request.

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