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.

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.

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.

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.

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.

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.
• 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.
• Worked on Customer Insight Studies, Engineered Standards, Time and Motion Studies, Workforce Training, and Workplace and Workflow Design.