Kevin Ashton Email & Phone Number

Plymouth, Mn

Head 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.

Plymouth, Mn

Minnetonka, Mn

Minnetonka, Mn

As 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.

Responsible 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.

Working 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.

Managed 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.

Held 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.