Michael Shirey Email and Phone Number

- Supervise and coordinate a team of quality and validation engineers in completing sitewide validation remediation including computer system validation, equipment qualification, and process validation - Lead and prescribe validation strategy for projects including: TMVs, Lyophilization, Packaging ISO 11607, Sterilization ISO 11135, Cleaning Validation, Cleanroom Validation, Process Validation

- Lead site validation efforts spanning multiple areas: temperature mapping, computer systems, quality control equipment, cleanroom, sterilization- Produce validation documentation including master validation plan, control plan, protocols- Audit support as site validation subject matter expert

- Supporting process validation efforts in an ISO 13485 based quality system to enhance class II medical device manufacturing- Responsible for writing, supporting, and executing process qualifications (IQ, OQ, PQ, TMV) within cross-functional groups that include software test engineers, IT personnel, and manufacturing engineers- Complete risk assessments and perform root cause analysis in support of deviations, CAPAs, and NCMRs - Drive Firmware-Over-the-Air process validation by drafting system requirements, drafting system qualifications and executing test scripts

I completed my master's research project in the Hearing Research Center in the Sen Lab. The title of my project is "Parameter Analysis for Cortical Network Model Solving the Cocktail Party Problem." In my project I optimized and simulated a computational model built in MATLAB by using shared computing cluster resources.

A major responsibility of this position was leading the company transition to the ISO 9001:2015 standard as well as conducting multiple continual improvement projects in a manufacturing facility. During my time in this position I led a full QMS internal audit in preparation for a registered body audit. I also oversaw multiple quality control departmental projects such as inspector training for NDT procedures.

This position was responsible for various aspects of design, production and quality of temperature instrumentation for petroleum refining and petrochemical industry. I contributed to several departments including the Specialty and Expedited Services Department, Capital Projects Department, and Surface Temperature Measurement Department. The internal engineer role at times required managing department workload independently as well as working in a diversified team of inside sales representatives and engineers. Work was completed in an often stressful and high paced environment.As a company engineer I also oversaw field engineering projects spanning such areas as project management, troubleshooting instrumentation, and supervision of on-site product installation. I completed both domestic and international field service projects during critical refinery shutdowns.

My research initially revolved around building a transducer and designing a thermocouple implant to chronically measure cortical brain temperature in the awake, behaving mouse. Applying my designs I was able to quantitatively determine changes in cortical brain temperature during varying states by utilizing advanced statistics and mathematical modeling. The research I helped lead resulted in my 82 page thesis, my formal defense, and a first-author publication.