Byron Sanders Email & Phone Number

Bloomington, Indiana, United States

Bloomington, Indiana, United States

Bloomington, Indiana Area

Indianapolis, Indiana

Indianapolis, Indiana Area

Ann Arbor, Mi

Participated in remediation activities related to a consent decree with the U.S. Food & Drug Administration (FDA) regarding quality system improvements at its Ann Arbor, Michigan facility. Created, established and implemented policies and procedures to control the design and development of software that will be incorporated into medical devices. • Created procedure to establish a structured way to create deliverables to ensure IEC 62304 standards are met• Worked with internal project teams as an IEC 62304 SME • Provided support to close CAPA related to product software design controls• Support creation of training materials for newly created procedures • Support of classroom training session provided as part of newly created procedures• Participate in working sessions with development team to create software design deliverables• Perform audit of software design deliverables to insure compliance to policies and procedures

Provide the support to manufacturing lines to ensure day-to-day support and functions in a team environment. Act as mentor within functional and cross-functional teams for technical guidance and identifying, applying, and resolving issues. Develop, establish and maintain quality engineering metrologies, systems, and current best practices to achieve and maintain regulatory requirements. Serve as a champion for the implementation of divisional and corporate Quality Engineering efforts and goals.Participate and support supplier changes and first articles Team with suppliers to identify root cause and aid in corrective action planMake decisions on risk assessment and product liabilityCreate strategies which reduce costs, optimize efficiencies and improve customer service Lean principles implemented on production lines such as Quality At The SourceProvide consulting service to other departments on the use of quality engineering methodsEstablish and execute effective corrective action plansReview and approve product, process, software qualification, validation and other controlled documentationProvide project direction, coaching, mentoring and removal of barriers for engineers, technicians, and team

Spencer, In

Quality support to manufacturing lines supplying day-to-day support and related tasks to maintain production schedule. Provided focused quality engineering support within the engineering group, manufacturing lines, system/services support and the materials group. Developed, established and maintained quality engineering metrologies, systems, and current best practices to achieve and maintain regulatory requirements. Served as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Participate in supplier audit, supplier changes, and supplier root cause investigationsParticipate as team member to drive changes in design and process to improve system and process reliabilityApplied systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesIdentify non-conformance events/trends and develop technical investigation plansInvestigates, analyze and implement solutions to customer/internal complaintsLead and support continuous improvement activitiesReview and approval of all changes related to process and validation documentationDevelop and update work instructions along with delivering product builder trainingMentor and develop new engineers and technicians

Lead validation remediation efforts for multiple product families. Remediation activities included review of post surveillance data to ensure product performance and to reevaluate current process control for effectiveness. Review of product specification and previous validation documentation to identify and correct gaps between the validated state and the current internal and external requirements. Lead team in developing and updating validation deliverables including Product & Process Qualification protocols and reports & Validation Plans. Creation of validation documentation (PQ, PPQ, MVP, MVR)Creation, validation and execution of Test Method and Test PlansPerformed statistical analysis for product and process qualification Identified and investigate out of specification test resultsEquipment development, creation and qualificationImplementation of process controls and monitoringTrained direct and indirect labor to manufacturing processes and Test MethodsLead team of engineers, technicians and co-ops towards validation completionWorked with cross functional team including R&D, Quality and Operations

Ms, Business Administration

Bs, Biomedical Engineering

Activities and Societies: NSBE Wrestling Team Track Team