Amanda Thompson Email & Phone Number

Westminster, Colorado, United States

Ensure compliance with Quality Management Systems (QMS), customer specifications, and industry standards (ISO 13485, AS9100) throughout all phases of the project lifecycle.Lead configuration management and document control activities, ensuring accuracy, traceability, and timely updates.Collaborated with cross-functional team to define and refine project requirements, ensuring they were Specific, Measurable, Achievable, Testable, and Complete (SMART).Develop and authored comprehensive test plans, verification procedures, engineering documentation, and test reports.Designed and executed Design of Experiments (DOE), including benchtop testing, to identify key parameters influencing system performance.Performed detailed data analysis to support Minitab analysis and DOE equation validation. Provided key support for ISO 13485 and AS9100 audits, ensuring compliance with regulatory and quality standards.

Westminster, Colorado, United States

Westminster, Colorado, United States

Boulder, Colorado, United States

Provide quality oversight of raw material release, additionally, support commercial operations in a contract manufacturing setting, with adherence to SOPs and FDA regulations. Author material specifications related to raw materials and consumables used in the manufacturing process. Assist in supplier complaints, deviations, change controls, CAPA, and investigations initiated in or impacting the QA Raw Materials Department.

Littleton, Colorado, United States

Utilized in-house 3D CAD software to create custom surgical splints and support product verification with FDA approved documentation. Assisted in build preparation for additive manufacturing.

Aurora, Colorado, United States

Collected and processed fish tissue samples for genotyping and gene sequence confirmation using Polymerase Chain Reaction and Gel Electrophoresis to identify and sort fish with targeted DNA sequences needed for research. Improved upon existing protocols to accelerate results to accelerate results without sacrificing validity.

Denver, Colorado, United States

Boulder, Colorado, United States

Worked in a cleanroom environment to build over 2000+ electrode pencils per day. Employed two manufacturing techniques (A3 and DMAIC process) to conduct research on the improvement of part identification during batch changes. Participated in a bi-weekly mentorship with a software engineer to create a proof-of-concept method to verify the input of a scanner against a list of product codes.

Centennial, Colorado, United States

Master'S Degree, Bioengineering And Biomedical Engineering, 3.9

"Validation of a Lung Function Measurement System and Predictive Single Compartment Model in a Two-Hit Murine Model of Acute.

Certificate, Data Science

Bachelor'S Degree, Bioengineering And Biomedical Engineering, 3.8

Certificate, Green Belt