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In 30 years of industry experience, I’ve developed an expertise in Quality, and a passion for building strong foundations in design and process excellence. I’m committed to delivering tools and systems to companies that help them achieve significant, sustainable financial results. I have earned a six-sigma black belt, a Certificate in data analysis, and the position of head of Quality for a multi-site, $500M manufacturing organization.I am known for implementing Six Sigma programs and Lean Manufacturing programs at several companies that have delivered significant cost savings. Strengths include leadership, problem solving, innovation, teamwork, coaching, process improvement, and teaching. Combining these strengths, I have proven myself to be a successful advisor and change agent, with the ability to lead, coach, or implement positive change across a broad organization. Specialties: Quality - Operational Excellence - Lean - Six Sigma Subject matter expertise in problem solving, DMAIC, CAPA system, Risk Management, Acceptance Sampling, Specification Setting, and Process and Test Method Validation. I have created and delivered training classes to hundreds of scientists and engineers in each of the above subjects, as well as in statistical techniques to support R&D and Manufacturing.
Summit Quality Consulting
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PresidentSummit Quality Consulting 2023 - Present
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President And OwnerSummit Quality Consulting Sep 2021 - Present
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Director Of Quality, AmericasProto Labs Jun 2014 - Mar 2024Plymouth, MnHead of Quality at Proto Labs, responsible for all aspects of the Quality organization. Responsibilities include ensuring company compliance with ISO standards, setting company Quality Goals and Objectives in alignment with corporate goals, developing our company culture of quality, and managing and developing the Quality team.
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Director Of QualityProtolabs May 2018 - Sep 2021Plymouth, Mn -
Director Of QualityProtolabs Jun 2014 - Sep 2021Minnetonka, Mn
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Quality ManagerAmerican Medical Systems Aug 2011 - Jun 2014Minnetonka, MnAs a Quality Manager, I've managed Quality Engineering, Supplier Quality Engineering, and Quality Systems departments. In addition to managing a staff of up to eight engineers, major responsibilities have included facilitating Risk Management, providing support and guidance for Design Verification & Design, Process and Test Method Validation activities, and continuous improvement of the Quality System. -
Principal Quality Systems EngineerAmerican Medical Systems Sep 2010 - Aug 2011Responsible for providing leadership in quality system refinement and development to meet global quality system objectives. This includes developing and maintaining quality system documents and training, and ensuring effective implementation of quality system elements to meet FDA and international quality system regulations and standards.• Built the company Test Method Validation program from the ground up. Authored the company procedure, developed and delivered the training program, and led the implementation by educating and supporting management as well as coaching several project teams.• Developed and implemented the company Process Validation program, including authoring the company procedures and training program.• Led the Quality Education effort by coordinating a dozen training and learning events in 2011. Led the prioritization activities, and assisted presenters in training material creation.• Successfully led a cross-functional team to implement improved standards, methods, and record-keeping practices for employee training.
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Senior Project AdministratorBeckman Coulter Jul 2007 - Sep 2010Working in the Quality organization, I develop and implement quality systems, as well as lead problem solving teams for complex projects. I have developed procedures and best practices for Process Development, Process Validation, Risk Management, Complaint Handling, Specification Setting, and the application of several statistical techniques.• Developed and implemented the company Risk Management program, including creating the company procedures and training program.• Developed and implemented the company Process Validation program, including creating the company procedures and training program.• Developed and implemented statistical training courses, including courses on Specification Setting, Acceptance Sampling, and use of JMP software.• Identified key improvements to the efficiency and effectiveness of the company’s complaint handling program.• Identified a fundamental flaw in the test method for carryover, and developed an improved method. -
Senior ScientistBeckman Coulter Nov 2003 - Jul 2007Managed the technical troubleshooting and product improvement projects for seven immunoassay products.• Developed process improvements for multiple processes that resulted in annual cost savings of hundreds of thousands of dollars. Improvements included a Prolactin Calibrator scale-up and process improvement, a PSA particle formulation improvement, and a GI Monitor formulation and process improvement.• Developed a statistically sound method for extending the shelf-life of serum controls. • Identified root causes associated with PSA instrument error codes and recommended resolutions.• Identified the root cause of an hCG conjugate failure, and implemented a resolution. • Trained other Tech Ops scientists in Specification Setting, Capability Analysis, the Six Sigma DMAIC Process, and the CAPA system.
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Senior ScientistAbbott Diagnostics May 1992 - Nov 2003Held positions with increasing levels of responsibility; from manufacturing technician, to development scientist, to senior scientist. Developed procedures, test methods, and specifications, and provided technical support for products in molecular diagnostics and immunodiagnostics.
Kevin Ashton Skills
Kevin Ashton Education Details
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Biochemistry
Frequently Asked Questions about Kevin Ashton
What company does Kevin Ashton work for?
Kevin Ashton works for Summit Quality Consulting
What is Kevin Ashton's role at the current company?
Kevin Ashton's current role is Helping manufacturers profit by improving efficiency and quality..
What is Kevin Ashton's email address?
Kevin Ashton's email address is ke****@****abs.com
What is Kevin Ashton's direct phone number?
Kevin Ashton's direct phone number is +176347*****
What schools did Kevin Ashton attend?
Kevin Ashton attended University Of Illinois Chicago.
What are some of Kevin Ashton's interests?
Kevin Ashton has interest in Employee Recognition, Training, Six Sigma Black Belt, Photography.
What skills is Kevin Ashton known for?
Kevin Ashton has skills like Quality System, Capa, Medical Devices, V&v, Validation, Six Sigma, Design Control, Iso 13485, Dmaic, Quality Control, Manufacturing, Design Of Experiments.
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Kevin Ashton
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Kevin Ashton
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