Victor D. Boatright

Qualifications Profile

Solutions-oriented Quality Engineer that has a Certified Quality Engineer (CQE) Certification & Six Sigma Green Belt (SSGB) dedicated to leveraging vigorous training and experience to increase production standards within high growth organizations and achieve corporate vision for growth.

Experienced Technical Project Manager focused on exceeding client expectations through delivery of sound methodologies to streamline processes through statistical controls and enhance production through continuous improvement.

Proven ability of Manufacturing Systems and Engineering Principles with business objectives to meet short- and long- range business objectives.

Adherence to FDA, GMP, cGMP, ISO 9001: 2015, ISO 13485:2016, ISO 14971, PPE EU 2016/425, CE, AS9100, FAI, and ASTM standards, along with the proficiency in Minitab, PowerBI, AutoCAD, SolidWorks, Track Wise, SAP, Veeva, and the Eastman S125 CMM machine. Education and Credentials

Master of Science in Technology Management – Quality Systems (2018) East Carolina University, Greenville, NC

Bachelor of Science in Industrial Technology, Manufacturing Systems Concentration (2013) East Carolina University, Greenville, NC; Cumulative GPA 3.6 (Magna cum laude) Associate of Applied Science in Mechanical Engineering Technology (2011) Computer Aided Design Certificate (2009)

Wilson Community College, Wilson, NC; Cumulative GPA 3.9 (High Honors) Certifications

Six Sigma Green Belt Certification - #10225 (SSGB) (2013) Certified Quality Engineer - #104273 (CQE) (2019)

American Society for Quality (ASQ)

Experience Highlights

Philip Morris International, Wilson, NC

Quality Engineer, (Mar. 2022 – Present)

• Provides technical Quality support and expertise to improve material, products, and Quality performances; Provide support for the review/update of the manufacturing process characterization.

• Conducts Non-Conformities Management Investigate in a timely manner non-conformities and deviations. Conducts corrective action / preventative action (CAPA) activities.

• Defines and supports the Quality Management System and supports the establishment of all related procedures supporting good manufacturing practices and approves all procedures.

• Performance as Lead Auditor and provide Audit Support Lead and/or make sure internal audits (self- inspections) including quality system audits, infestation control, external audits, corrective actions identified, followed-up and documented.

• Collaboration Ensure a strong partnership with internal/external stakeholders focusing on collaboration and information exchange to ensure excellent quality and compliance with the plant’s requirements, standardization, and continuous improvement; promotion of plan of execution of internal and external training of all TRIAGA employees, as subject matter expert in QMS, quality process and product to drive and share excellence within TRIAGA.

• Conducts site leadership activities in risk mitigation and assessment for organizational success through strategic FDA Audit preparation.

• Implements all Supplier Quality Management activities to promote supplier qualifications and success.

• Performance as Associate Radiation Safety Officer duties and responsibilities with EH&S Department.

• Health, Safety & Environment Promote and apply all rules concerning TRIAGA Quality, environment, health, and safety. Report all situations requiring actions to minimize or eliminate risks exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable Law requirements and Company standards.

• Functions as sites Associate Radiation Safety Officer (ARSO) for operations radiation gauge. Philips, Cambridge, MA (Contractor)

Quality Engineer PM Consultant I, (Jan. 2022 – Mar. 2022)

Coordinates project planning on key corporate CAPA programs (CAPA Engineer); Works with subject matter experts to develop plans and execute corrective action activities to resolve audit findings.

Performs risk assessments for CAPA phases of the opening, investigation, action plan, implementation, effectiveness check, and closure to promote organizational continuous improvement.

Leads teams in using problem solving tools and sound statistical analysis to find root causes of product and process issues to meet regulatory requirements and process improvement goals.

Effectively apply quality engineering knowledge and project management expertise to support initiatives and solve business problems, assist with data analysis, change management, deviations, and nonconformance reports for all required data submissions.

Tracks and reports weekly during project reviews on status, successes, issues, and slippage; budget and spending status if appropriate; next steps in the project effort to complete needed tasks along with other key project metrics resource management; determine roles of cross-functional team members based on project requirements, timeframes, and budget.

Manages multiple project teams and resources towards project successes; Facilitates (competencies) required for team members based on project specifications and requirements; creates or participates in the creation of project documentation, documents, budgets, costs, timelines, checklists, status reports, etc. evaluates key deliverables and final product to ensure traceability of requirements, high quality and acceptance, communicates progress, risks, expectations, timelines, milestones and other key project metrics to clients and team members.

Coordinate meetings, ensures Project Plans stay on target; stay on top of Philips employees and make sure they are on task; coordinate activities and make sure dates are correct. Collins Aerospace, Wilson, NC

Quality Engineer, (July 2021 – Dec. 2021)

Reviews and makes recommendations for Quality Assurance plans, guidelines, policies, and processes that support the achievement of Quality targets for the Aerospace QMS.

Performed disposition of nonconformances reported to the Quality Clinic for root cause analysis.

Coordinated with Audit Team for preparation and a successful passing of the AS9100 audit.

Conducts Quality Assurance processes to ensure overall quality is continuously improving.

Provides defect analysis in the plants Quality Clinic in dispositioning through root cause analysis and CAPA to ensure quality standards comply and proposing quality improvements.

Collects and analyzes quality information for the development of quality strategies and programs.

Analyzes quality improvement processes to ensure on-going reductions in Cost of Poor Quality (COPQ) and escapes.

Biogen, RTP, NC (Contractor through Randstad)

Quality Assurance Associate II (PO&T), (May 2020 – Oct. 2020)

As a Quality Associate II responsible for supporting key functional, tactical, and operational aspects of the Aseptic Processing/Sterility Assurance and QC Sample Control group at Biogen. Adhered to compliant cGMP documentation practices, possesses a fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions.

Review of executed Master Batch Records (MBR), Batch Production Records (BPR), and Solution Lot Records (SLR) to support product discrepancies in GMP standards through documentation review on a day-to-day basis.

Performed root cause analysis through risk assessment, change management, deviations, and nonconformance reporting.

Validated manufacturing equipment on the manufacturing floor as the prerequisite of approval for use in production through the autoclave process through electronic and paper recording systems. Corning Inc., Newton, NC (Contractor through Mastech) Quality Engineer II, (July 2019 – Oct. 2019)

As a Quality Project Engineer lead a portfolio of projects to improve the Quality Management System of their fiber optic cable plant. Strengthened the Product Quality Architecture within the plant by driving fundamental understanding to positively influence the Quality Management System.

Lead and supported projects to deliver significant operational performance improvements, reliability, process control, risk assessment, capability analysis, design verifications, process design, review change control, and cost control.

Worked with leadership to identify, prioritize, resource, and manage opportunities for QMS improvements through deviation initiative, CAPA, FMEA, DOE, SPC, MSA - Gage R&R, and Minitab 19 data analysis.

Collaborated and trained operators, team leaders, process engineers and other specialists to identify and implement improvements to our Quality Management System through RMAs and (NCR) functioning.

Conducted verification and validation testing for research & development projects to launch new product development and product improvements.

Understood internal and external customers stated and implied needs as well as fulfilling their expectations every time by monitoring, maintaining, supporting, and continuously improving plant quality systems.

Worked with various levels of plant and division management regarding quality and quality-related actions, including Division Audit preparation and compliance (Product Line Management, Engineering, Sales, Customer Service, Scheduling, Production, Inter-Plant, Inter-Division); conducted plant 5S audit training and compliance.

Revlon, Inc., Oxford, NC

Production Supervisor / (Quality/Packaging Engineer), (Oct. 2018 – Apr. 2019) Architected and implemented manufacturing line performance process improvements in a GMP and FDA regulated environment to stabilize systems and establish lean processes to drive production and reduce expenditures.

Managed a Six Sigma Black Belt project as the project leader by holding accountability for weekly failure analysis reporting, defect trend monitoring, as well as root cause analysis, resulting in streamlined production that increased line performance by 70% and eliminated 85% of waste through implementation of the six sigma methodologies, along with the use of quality core tools, Minitab analysis, SPC, DOE, PFMEA, FMEA, Process Validation (IQ/OQ/PQ), CAPA and advanced data analysis. SSBB Project had an overall cost savings of $719,000 after adherence of a six-sigma quality level.

Achieved 97% increase in GMP compliance & regulatory guidelines, departmental safety, quality, and production goals, including a changeover program, cleaning, aseptic processing/sterility assurance, and processing, through effective mentoring and coaching of shift teams; ensured change management practices as production supervisor responsibility.

Increased focus on quality standards in production and laboratory environments, performing torque, pull, vacuum, heat and drop testing, as well as verification that product design control documents and drawings that met/exceeded quality specifications in packaging design; ensured six sigma quality level in specifications and packaging design.

3C Store Fixtures, Wilson, NC

Quality Engineer Intern, (May 2018 – Aug. 2018)

Teamed with Quality Engineering Team to apply lean manufacturing and six sigma concepts for the improvement and optimization of production systems.

Conducted a value stream mapping project to streamline flow, increasing production and specifically increasing Value Added Time (VAT) by 63% through cycle time and takt time analysis, line balance, and inventory reduction to establish continuous flow and continuous cost savings.

Drove green belt projects utilizing six sigma methodologies through the quality core tools, such as CAPA, root cause analysis, 5 Why’s, FMEA, PFMEA, and data analysis in defect reduction efforts within Imported Goods division, achieving defect reduction by 53% and achieving Six Sigma quality level.

Implemented 5S project, investigating deficiencies to resolve production failures and close systemic quality gaps in production rates while mitigating errors and inefficiencies, recreating the SOP documents.

in the plants Paint Division and increasing workflow through the improvement of the plant layout. OPW Retail Fueling, Smithfield, NC

Industrial Engineer Intern, (Aug. 2017 – Nov. 2017)

• Conducted continuous improvement activities through the application of lean methodology for overall process streamlining and cost savings for quality in conjunction with ECU MS Lean Enterprise course.

• Worked together with machine operators learning manufacturing processes and applying lean methodologies for quality improvements.

• Performance of weekly Gemba walks with engineering team for organizational improvements in quality, manufacturing, production.

• Performed the technical writing of all plant SOP documents and ensured the compliance of procedures for quality along with manual redesign, analyzing current processes to identify gaps/areas of opportunities of continuous improvement; assisted in product development projects in design controls. AT&T, Raleigh, NC

Wire Technician (Oct. 2016 – May 2017)

• Conducted electrical wire configuration for the installation of TV service, satellite, and state of the art fiber optics for customer quality and service measures.

• Applied advanced electrical troubleshooting to resolve technical problems during installation and all repair services.

• Dispatched effectively and efficiently to set up appointments and repair of electrical issues in a timely response to customers.

• Adhered to time standards and safety regulations while performing all job duties.

• Monitored and adhered to all-in quality metrics.

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