Katie Erdley Email & Phone Number

Loveland, Colorado, United States

Following the Mars/Antech acquisition of Heska in June 2023, was selected for a promotional opportunity to VP of Global Ops.

Loveland, Colorado, United States

Following the Heska acquisition of LightDeck in January 2023, was selected for a promotional opportunity to VP of Ops.Played a critical role in strategic decision-making, planning, coordinating, and generally overseeing all functional operations activities in the areas of procurement, purchasing, receiving, inventory stock management, supply chain and logistics, import/export, packaging, and multi-location warehouse pick/pack/ship sales order distribution. Ensured development and implementation of efficient and cost-effective systems, processes, and procedures that comply with internal and externally regulated requirements to meet current and future commercial needs and goals.

Boulder, Colorado, United States

-Senior leader within the organization, drove executive-level strategic planning and decision-making to ensure alignment of resources and efforts with corporate priorities -Multi-site, multi-shift responsibility, managed day-to-day activities of a dynamic operations environment where timely communication and issue resolution were key-Leadership of a 30-person team including manufacturing, warehouse, quality control, and formulation groups-Managed $10M, 64k sf facility build-out, including 14k sf clean room and 4k sf cold room, which resulted in a 30x capacity scale up to 1MM units /mo-Scaled existing high-mix diagnostics manufacturing line, at a separate location, ramping up from 25k units/mo to 50k units/mo; a 200% increase in production with only a 60% increase in operations staff-Implemented lean manufacturing concepts and quality mindset throughout the entire operations process while ensuring compliance to ISO 13485, FDA, OSHA, and EPA. No regulatory or audit findings during time in role

Boulder, Colorado, United States

-Championed quality mindset within the organization through interdepartmental engagement and service-based approach-Served as Management Representative for QMS and Official Correspondent for FDA-Led, authored, and submitted regulatory submissions including FDA Emergency Use Authorizations (EUA), FDA Q-submissions, and EPA Low Volume Exemptions (LVE)-Built a 20-person team including quality assurance, quality control, regulatory affairs, clinical operations, and program management, to support a rapidly growing organization-Managed national, multi-site clinical studies for COVID EUA Point of Care products

Boulder, Co

f/k/a MBio Diagnostics-Built and implemented Quality Management System from the ground up with a focus on efficient, collaborative compliance and delivery of high-quality products-Achieved certification of QMS to ISO 13485:2016 under Medical Device Single Audit Program (MDSAP) with no findings-Served as Management Representative for QMS and Official Correspondent for FDA-Drove completion of Stage Gate Design and Development deliverables for COVID-related product

Bellefonte, Pa

•Led ISO 13485 certified and ISO 14971 complaint quality system.•Transitioned QMS from 2003 to 2016 revision of ISO Standard•MDSAP participant with significant audit success•Ensured design and manufacturing compliance to ISO 13485, ISO 14971, 21 CFR 820, and Medical Devices Directive 93/42/EEC, with a focus on proactive risk management while maintaining innovative development.•Guided best quality system practices to ensure that Design History Files, Device Master Records, and other documentation follow the 7–stages of development.•Interacted with clinicians, vendors, and other stakeholders to develop high-value, innovative medical devices. •Developed and wrote government and commercial proposals in the area of active medical devices to build the business base of AMI.

Bellefonte, Pa

•Managed a mission-critical program through validation and verification, safety and efficacy testing, FDA 510(k) Pre-Market Notification submission, and product launch.•Prepared and scaled-up manufacturing efforts including work flow set-up, process definition and optimization, ISO 13485 compliance, and training of assembly technicians.•Developed and maintained ambitious and appropriate project and production schedules.•Interacted with clinicians, vendors, and other stakeholders to develop high-value, innovative medical devices.•Developed and wrote government and commercial proposals in the area of active medical devices to build the business base of AMI.

• Pharmaceutical analytics in support of sales and marketing strategy consulting• Worked on incentive compensation and customer segmentation projects • Responsible for project management including resource tasking, load balancing, scheduling, and customer communication• Traveled to India to work with and train a parallel team to produce high-quality deliverables on a demanding project schedule. • Improved deliverable quality and reduced cycle time by designing and implementing new process tools using automation and embedded quality / error checking algorithms• Performed real-time structured and unstructured analysis of various data sources using Excel®, SAS®, and other database tools

•Improved workforce performance and eliminated waste through the implementation of Industrial Engineering and Lean techniques on consulting projects focused in Grocery, Apparel, Hardlines and Pharmacy environments•Utilized Accenture/Maynard software, tools, techniques, and methodologies, along with my own skills and observations, to identify, analyze and quantify improvement opportunities in labor efficiency at several operations in the Retail Sector•Worked on Customer Insight Studies, Engineered Standards, Time and Motion Studies, Workforce Training, and Workplace and Workflow Design.

•Improved workforce performance and eliminated waste through the implementation of Industrial Engineering and Lean techniques on consulting projects focused in Grocery, Apparel, Hardlines and Pharmacy environments•Utilized Accenture/Maynard software, tools, techniques, and methodologies, along with my own skills and observations, to identify, analyze and quantify improvement opportunities in labor efficiency at several operations in the Retail Sector•Worked on Customer Insight Studies, Engineered Standards, Time and Motion Studies, Workforce Training, and Workplace and Workflow Design.