Darko Marquez, Pmp® Email & Phone Number

College Station, Texas, United States

● Managed a diverse portfolio with 5 different programs and 3-5 active projects per program using traditional and agile project management methodologies● Developed and implemented a packaging innovation that led to a 50% reduction in produced cost for a product while also incorporating sustainable materials which led to a new Patent: (U.S. Provisional Pat. Ser. No. 63/536548, sole inventor)● P&L responsibility, Budget ($1.2MM) Planning/Preparation, Cost Control, and Financial Reporting● Aligned Quality Management System based on US FDA regulations to ISO 13485:2016, allowing the company to present value to products in international medical device markets

College Station, Texas

• Appointed as Management Representative to oversee all aspects of the Quality Management System. • Employ control and authorization over operations, including production, applications development, research and investigation, inventory, and supply chain.• Collaborate with senior executives in devising and implementing innovative strategies aimed at driving company growth.• Originated, designed, and launched an effective resource and process tracking system.• Generate a comprehensive report utilizing the tracking system detailing where resources were utilized and how much time was spent on each process.• Cultivated professional relationships with outside suppliers, including raw material, lab equipment, shop equipment, and service providers, utilizing Value Stream Mapping, in order to negotiate optimal pricing and terms. • Streamlined supply chain procedures by creating and implementing a real time inventory management system in Excel.• Heighted production throughput significantly from 85% to 95% with zero loss in yield.

Bryan/College Station, Texas Area

• Directed and oversaw a specialized engineering and lab team of up to 20 inter-departmental members with a concentration on receiving, producing and shipping a quality product. • Produced an in-depth pricing model founded in cost accounting which empowered Exothermix to set a value on custom products based on direct and indirect costs, variable and fixed costs, and overhead.• Spearheaded an application development program while simultaneously controlling up to ten active projects across five different markets.• Administered all resource scheduling, including people and equipment, for lab and production departments.• Initiated Lean Manufacturing principles to embed a lean culture throughout the organization with the goal of minimizing waste and enhancing workflow.• Headed and positively completed an FDA audit for a Class I Medical Device Manufacturer (21 CFR Part 820).• Headed and passed an audit from the Texas Department of State Health Services.

Bryan/College Station, Texas Area

• Oversaw and implemented a new Quality Management System based on FDA’s 21 CFR Part 820 and ISO 13485 which consisted of over 30 SOP’s in 5 categories (Management Controls, Designs and Document Controls, Corrective and Preventive Action, Production and Process Controls, and Material Controls).• Facilitated the development and implementation of a streamlined process flowchart for production lines.• Operated as key team member that advanced productivity from 50M units in 2015 to over 3MM units in 2016.• Presided over several complex factory and site acceptance tests (FAT’s and SAT’s) concerning pilot production lines, ensuring all equipment adhered to established specifications.• Served as primary point of contact for clients regarding technology and design transfers, including customer onsite audits.

Bryan/College Station, Texas Area

• Structured, launched, and oversaw the quality program for the company’s inaugural medical device production.• Completed the process to obtain FDA registration for Exothermix as a Class I Medical Device Manufacturer.• Achieved success in guiding the company through its first medical device customer audit.• Utilized SAS JMP® statistical analysis software to guide and expedite product development.

Bryan/College Station, Texas Area

• Ensured compliance to Six Sigma DMAIC and DMADV processes in order to advance the safety profile of Exothermix products.• Advised management regarding materials selection and process enhancements, ultimately increasing product shelf-life from three months up to five years.• Collaborated on the scale-up of core technologies from bench-scale to pilot-line production.• Redesigned the composition of the base technology to reduce safety hazards