Quinn Whitlock

Experience

1. VP of Operations

   Biofire Defense

   Sep 2017 — Present · Salt Lake City, UT, US

   Provides direction over the maintenance and streamlining of the Quality Management System to ensure quality for all products and to meet Quality System Requirements (QSR) for the FDA (21 CFR), ISO 13485 and/or 9001. Oversees company compliance with US FDA, ITAR, OSHA, EPA, and other applicable government regulations (including EU, Canada, CE, and other nations where BioFire Defense sells products) and identified standards.• Act as an interface for the company on issues related to Quality Assurance and regulatory compliance, including inspections by regulatory agency representatives, Notified Bodies, or third parties.• Oversee the planing, direction, and coordination of activities of Injection Molding production area for design, manufacturing, validation of tooling, molds, and automation, ensuring that procedures and complete sets of documentation are developed and provided to the manufacturing group for each program.• Participates in the planning, development, implementation and evaluation of key business and performance goals, short and long-term strategic planning and objectives, plans, budgets, programs and policies. • Develop best practices for operational excellence within the manufacturing operations departments.• Work actively on gross margin improvement through annually planned COGS reductions.• Provides technical and managerial leadership to managers within the Instrument production, Service, Manufacturing Engineering, Supply Chain, Injection Molding, BioChemistry, and Reagent Manufacturing departments. • Ensure effective fulfillment of design transfer for new and changed product development, validation and market release phases.• Interface across organization to ensure product forecasts are utilized to drive inventory fulfillment and maintain product integrity. • Provide input into strategic direction for development and implementation of new initiatives, policies and programs related to operations.

Education

• University of Utah

  Bachelor of Applied Science (B.A.Sc.), Behavioral Science and Health

  2003 — 2004

• University of Utah

  Executive MBA, Business Administration and Management, General

• Salt Lake Community College

  Associate of Science (A.S.), Humanities and Science Education (Social Science)

  1999 — 2002