Quality Supply Chain

DUSTIN T. SMITH

**W*** Walz Dr., Wheaton, IL **189

Cell: 630-***-**** : **************@*****.***

Executive Profile

High performing Executive with 11 years of manufacturing, production,

engineering, supply chain, and quality leadership experience. In-depth

knowledge of quality management and leadership at the executive level

driving organizational and process improvements through Lean and DMAIC

methodologies while instituting best practices from large to startup

organizations. Demonstrated proficiency in staffing, training and

development, budgeting, project management, creation and execution of

company and departmental goals and objectives.

Skill Highlights

. Leadership/communication skills

. Human resource management

. Start-up to Fortune 500 experience

. Strategic planning and execution

. New product development

. Process development and improvement

. Quality systems management, development, creation

. Supply chain management and development in domestic and global supply

chains

. Problem solving - root cause analysis

. Risk Analysis

. Lean Manufacturing

. Six Sigma

. ISO 9001/13485/14001/14971

Professional Experience and Accomplishments

OrthoHelix Surgical Designs, Inc (Division of Tornier, Inc.) Medina, Ohio

Vice President of Quality & Regulatory Affairs, (2/2012-Present)

Multi-functional role with responsibility and management of the company's

quality management system and conversion to ISO13485, FDA regulatory

compliance to 21 CFR Part 820, total company quality initiatives, supplier

quality, inspection, and global quality system harmonization. Senior

Leadership team member assisting in strategic and operational planning,

policy and goal development, and budget creation and refinement.

. Management of company document control and establishment of enhanced

change control policies and procedures.

. Standardization of inspection methods, policies, documentation, and

techniques

. Reduction of sampling plans via supplier capabilities assessments and

statistical process control

. Incoming quality improvements from DPMO of 178,000 (82% FTY) to 72,000

(92% FTY) from 2010 to 2012

. Establishment of Supplier Risk Assessment over multi-commodity supply

base incorporating capacity, lead time, delivery and quality

performance over 3 year cycles.

. Lead due diligence activities focused on quality and regulatory affair

through acquisition of company in October 2012.

. Food and Drug Administration inspection lead, responsible for company

and system preparation and audit oversight and facilitation with

investigator.

Director of Quality, (9/2009-2/2012)

Responsible for the management of supplier quality and inspection

department. Planning and development of inspection personnel and supplier

quality for 79%(2009), 63% (2010), 50% (2011) growth and volume increase

YOY. Lean initiatives for process flow, cell layout, and inspection

throughput. Strategic planning and development of company and departmental

initiatives while aligning personal and direct report goals and objectives.

. Recipient of 2011 Quality Magazine - Quality Leadership 100 rated at #80

. New supplier quality initiatives - performance metrics, monitoring,

development

. Establishment of supply chain redundancy through commercial and quality

requirements and improved VMI agreements

. Oversight and establishment of Health Care Professional Compliance

program aligning policies and procedures to federal regulations and

requirements

Director of Supplier Quality, (11/2008-9/2009)

Responsible for the creation, implementation, and documentation of the

supplier quality management system including supplier selection,

assessment, development, and design transfer to supplier manufacturing.

. Created and established the supplier quality program including the

creation and updating of necessary procedures, policies, manuals and

tools.

. Formalized the supplier assessment program, supplier acceptance

criteria and lead supplier assessment of all current and new suppliers

. Created and formalized product transition and new product development

processes with new and current suppliers

. Created and maintained all supplier performance metrics, monitoring

performance and driving improvement

. Assisted Engineering in the development of inspection methods,

techniques, and gaging for all products with a focus on commonizing

part families/types

. Responsible for all supplier issues and non-conformances, CAPA, and

investigation.

Eaton Corporation - Airflex Division, Cleveland, Ohio

Senior Supplier Quality/Development Engineer, (07/2005-11/2008)

Responsible for the creation and implementation of a Supplier Quality and

Development program at the plant level across three locations - Cleveland,

Ohio, Juarez, Mexico, and Shanghai, China. Development of required

policies and procedures in conjunction with all Supply Chain and

Procurement activities and requirements.

. Provide technical leadership for continuous improvement of supplier

quality working closely with a wide range of commodities/suppliers

(machining, castings, forgings, weldments, hardware, coatings,

friction material, rubber)

. Perform domestic and global supplier capability and quality

assessments/audits/surveys

. Drove overall supplier DPMO down to 1427 (2007) from 4483 (2006)

across a total of 450+ suppliers and 25,000+ part numbers. Drove

overall supplier cost of non-conformance to $229K (2007) from $351K

(2006).

. Project management and team lead for the launch of new products and

move of existing business to new suppliers (NPI, outsourcing, and

supplier transitions) working in conjunction with Purchasing and

Engineering.

. Supply Chain Management leadership representative for Quality driving

improvement within the internal organization for all SCM business

practices.

Ford Motor Company, Ohio Assembly Plant, Avon Lake, Ohio

Body Manufacturing Engineer, (04/2003-01/2005) & (5/2005-7/2005)

Independent manufacturing engineer responsible for managing statistical

process control and data collection of significant characteristics (SC) for

third shift body shop in manufacturing of the Escape/Mariner and Econoline.

Lead Variability Reduction Team for Sheet Metal improving SC data while

minimizing manual final fit of closures improving dimensional integrity and

capability.

. Responsible for manpower rebalance tasks - new process development

station to station creating standardized work, utilizing continuous

flow, error proofing, and total productive maintenance

. Root cause/analyze/repair quality, welding, body defects through

systematic problem solving techniques

. Troubleshoot tooling, fixturing, part, welding, dimensional, and

quality concerns

. Managed (4) direct reports - CMM and SPC technicians (UAW)

. Manufacturing representative/liaison between Ohio Assembly Plant and

Lorain Assembly Plant in regards to body shop issues/concerns, root

cause analysis, and corrective actions for process and vehicle

improvements between the two plants

Weld Engineer, (01/2005-05/2005)

Temporary assignment assuming responsibility and management of the

Escape/Mariner Body Shop Welding Program. Maintained 99% weld quality

ranking the Ohio Assembly Plant number two in North America. Establish and

maintain the Weld Control Plan while improving weld performance and

resolving complex welding issues.

. Manager of Weld Tear Down and Surveillance group - 2 shifts; 8 direct

reports (UAW)

. Ensure program compliance with QOS, ISO, Federal and Corporate

mandates and standards.

Education

University of Dayton, Dayton, OH: Bachelor of Mechanical Engineering

Ford Motor Company, Certified Six Sigma Black Belt

. $160,000 Savings in hidden factory costs and warranty related concerns

. Overall improvement in customer satisfaction based on warranty (JD

Power)

. Process/Tooling improvements and Capability improvement - utilizing

standardized work, process control, and error proofing

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