- Candidate 5QE has a BS in Electrical Engineering and is Six Sigma Black Belt and Lean Manufacturing Certified. He has extensive quality manufacturing experience and 20 years of management experience.
- He has worked in multiple industries including automotive, defense and medical device (FDA regulated).
- He has supported ISO9000, TS16949, AS9000, and ISO13485 quality management systems, he has performed root cause analysis and implemented corrective and preventive actions, he has Supported and maintained the Corrective and Preventative Action Functions (CAR/PAR), participated in Kaizen Projects, and performed processes analysis and process monitoring utilizing the Six Sigma Methodologies.
- He has owned his own company and was charged with developing and implementing ISO, TS, and AS quality management systems from scratch for multiple industries. So he is an expert as providing solutions utilizing fundamental principles of quality.
- He has 20 years experience as a Manager. He is a collaborative manager, he listens to his employees. He communicates in an intelligent and respectful manner and always makes sure the job is done well.
- Candidate 5QE is located in TN
- Candidate 6QE graduated from Southern Polytech with a Bachelor’s degree in Mechanical Engineering in 2012.
- His initial work experience was as a Process Engineer where he got a great deal of exposure to the textile manufacturing industry. His roles included directly involved in process and product improvement as well as standardizing and auditing processes for improved quality. He was also involved in conducting internal audits to prep for their customers’ quality audits.
- In his current role he is responsible for ensuring part quality and supply chain efficiencies as driven by a highly regulated industry.
- He has utilized SPC and Minitab to track upper and lower control limits. When findings revealed an out of spec condition, he issued a return to the supplier, and then re-evaluated lots against a control batch.
- He has experience with working with machined, stamped and molded parts including composites
- He currently works by driving successful communication and process improvement. He has improved quality and on-time delivery and able to improve Supplier Quality Scores within the last year by 10%
- He would consider a move into a company where he has a clearly foreseeable growth trajectory.
- Candidate 6QE is located in Georgia
- Candidate 7QE has a BS in Biology and is Yellow Belt Lean Six Sigma Certified. She specializes in ensuring compliance with quality and standards, executing strategies for improvements and solutions, and staff training and development.
- She is experienced in working with cross-functional teams and groups, she has implemented preventive actions while ensuring compliance to quality standards and processes; and managed numerous projects and programs.
- She has authored validation protocols for re-validation processes; aligned industry standards and site requirements with new Standard Operating Procedures.
- She has prepared and scheduled equipment for validation protocol execution, and finalize validation summary reports. She has worked in a Quality Validation role, where she performed Quality reviews of vendors.
- She has experience in FDA Regulated environments and ISO standard Grade A + B facilities. She has experience working in worked in Pharma, Blood Bank, and Diagnostic testing industries
- Candidate 7QE is located in Georgia
- Candidate 8QE has a BS in Chemical Engineering, Masters in Management and 6 years experience in Validation/Quality.
- He is Lean 6 Sigma Green Belt Certified. He has extensive experience using Lean Six Sigma tools to support process improvements.
- He has worked on cross functional teams with engineering during validation and commissioning of new equipment and processes.
- He has experience working in FDA and ISO environments on batch and semi continuous processes. He has a thorough understanding of cleaning validation, food safety and cGMPs, with a strong focus on quality.
- Candidate 8QE is located in Georgia.
- Candidate 9QE is a Chemical Engineer with over 20 years of experience in GMP regulated environments.
- She is experienced on equipment qualification, process validation, test method validation, computerized systems validation, aseptic processing and controlled areas and environmental controls
- She is experienced on Design Controls through manufacturing for medical devices and biological products.
- She has been a Quality Engineer for over 10 years and a Supervisor for over 8 years, she has managed up to 7 direct reports.
- Candidate 9QE is located in Georgia.
- Candidate 10QE has a Masters Degree in Mechanical Engineering.
- He is someone with STRONG process knowledge- he has worked with a variety of processes and can adapt to different processes, he has strong problem solving skills, he understands process oriented thinking, he asks the right questions to discover what is wrong with the process and he has a strong understanding of measurement methodologies.
- He describes process oriented thinking as: “If possible, I will first observe an issue, and speak with the operators/technicians who were working at the work site to analyze the root causes of the process. I will then review the procedure if the process has been working properly. I will create a report to discuss with the manager to solve it.”
- He has used CAD, CMM and Vernier caliper measurement methodologies. He has used UG-NX, CATIA, and AutoCAD and created 2D and 3 D drawings. He is familiar with ISO, JIS, and ASTM standards.
- Candidate 10QE is located in Georgia