Kevin J Frisby15850 N. Thompson Peak Parkway, Apt 1116, Scottsdale, AZ • 85260 • (480) 370 3749 • kevin.frisby@gmail.com

SENIOR QUALITY MANAGEMENT AND TRAINING PROFESSIONAL

A results-oriented quality management professional with extensive experience in business transformation, project management, quality control, regulatory affairs, biotechnology and driving continuous improvement initiatives, predominantly in the medical field.

Core competencies include driving a quality culture, supplier development, business process management, change management, automation, and designing quality metrics.

Self-motivated and hardworking with a high degree of flexibility, creativity, resourcefulness, commitment, and optimism.

Strong ability to work with demanding time schedule to meet goal deadlines, always with an eye for detail.

Well versed in ISO 9001, FDA 1270/1271 and knowledgeable in Lean Management Principles.

Certified instructor for a wide variety of training programs and licensed with the Arizona Department of Public Safety and trained by Indiana Public Safety Training Institute.

CORE COMPETENCIES

Quality Management, Lean Principles, Process Improvement, Biotechnology, Training & Education, Curriculum Development, Project Management, Stakeholder Management, Supplier Management, Leadership Skills, Budgeting/

Forecasting, Operational Excellence, Risk Management, Analytical Skills

KEY ACHIEVEMENTS

20 Years of dedicated service in Emergency Medical Services - Indiana EMS Commission

Provided quality training and education to thousands of adult learners

Certificate for Outstanding Service - American Heart Association

Successfully developed and implemented a quality system resulting in the company receiving prestigious industry accreditation after passing stringent federal inspections and audits

Played pivotal role in establishing a new human allograft tissue bank

Served as a member of a national stroke study which changed the way stroke victims are treated today

EDUCATION / CERTIFICATIONS / MEMBERSHIP

Undergraduate Level Paramedic Program, 1992Firefighter 1 CertificationCertified CPR/ First Aid/ AED Instructor - EMS Safety Services Inc.Certified Emergency Medical Services Primary Instructor – Indiana Public Safety Training InstituteCertificate for Outstanding Service - American Heart AssociationCertified Tissue Bank Specialist - The American Association of Tissue BanksCertificate of Appreciation for 20 Years of Service - Indiana Emergency Medical Services CommissionCertificate in Biostatistics – Grifol’s Inc.Elkhart Central High SchoolMember of the American Society for Quality (ASQ)

PROFESSIONAL EXPERIENCE

LATTICE BIOLOGICS INC, SCOTTSDALE, AZ Jun 2014 – PresentDirector – Quality/ Regulatory AffairsServing as the American Association of Tissue Banks Quality Council Member and Management Member with Executive Authority.

● Leading industry best practices, business excellence approaches and ensuring appropriate metrics are created, delivered, maintained and improved based on business and client needs.

● Key player in analysis, development and implementation of strategic business plans/policies, ensuring organizational growth while targeting maximum profitability and cost effectiveness.

● Managing a quality department team to plan, organize, and manage internal procedures and resources to ensure maximum productivity saving $200k in the first 6 months through process and staffing changes.

● Leveraging extensive knowledge of quality concepts, process development, operational analysis, business process re-engineering, project management and leadership to facilitate improvements in performance.

● Supporting quality improvement and control functions with business process re-engineering.● Developing and maintaining the Quality Systems Manual compliance with all current federal, state, local laws

and regulations of the FDA, AATB, ISO, and other applicable regulations.● Developing, implementing and managing all SOPs and other procedures, quality of operations and

compliance with FDA Current Good Manufacturing Practices (cGMP) and Good Tissue Practices (GTP).● Coordinating all regulatory, registration and accrediting inspections, and investigating all deviations,

complaints, adverse reactions and pre and post donation events.● Auditing key processes, optimizing workflow, improving organizational culture, while providing consultation

with leaders on ideas and execution, and implementing quality standards and continuous improvement in all areas.

ANDERSON SECURITY AGENCY, PHOENIX, AZ Mar 2011 – Jun 2014Vice President – Quality/ TrainingBuilt an ISO 9001:2008 Quality Management System and brought the educational programs up to date.

● Designed and taught a variety of educational programs to meet the needs of security professionals.● Ensured strict compliance with all corporate requirements and developed new quality policies and procedures.● Provided training to security professionals in the areas of laws, regulations, CPR/First Aid/AED and more.● Managed multiple special projects, studies and reports along with overseeing aspects of Information

Technology services and software and database administration.● Provided strong leadership, communication, technology and business skills to coordinate, facilitate and deploy

institutionalized solutions.● Identified areas of improvement in efficiency, productivity, accuracy; and managed growth for all teams.● Actively involved in standardization and compliance with policies, standard operating procedures; supported

the sharing of best practices.

GRIFOL’S-BIOMAT PHARMACEUTICALS, PHOENIX, AZ Jun 2008 – May 2010Quality Manager Southwest RegionEnsured compliance with regulatory and corporate requirements; supervised staff training across three states.

● Conducted detailed analysis, identified root causes, implemented corrective actions and prepared detailed reports.

● Conducted internal and external audits, reported all findings and coordinated all audits by the Food and Drug Administration, European Union and other agencies.

● Responsible for driving employee productivity, defect reduction, lead-time reduction, and timely delivery. ● Defined quality standards across all functional areas and periodically reviewed performance with the

application of concurrent management audit procedures.● Developed and promoted collaborative partnerships with stakeholders, and oversaw the execution and

delivery of operations, programs and services,

RTI DONOR SERVICES, INC. (TISSUE BANK), PHOENIX, AZ Oct 2001 – May 2004Quality Assurance ManagerResponsible for business & customer development while establishing new tissue bank. Played a pivotal role in receiving subsequent AATB accreditation and a successful FDA inspection.

● Led 58% improvement in productivity within first 6 months in business and ensured compliance with (FDA, AATB, HIPPA, OSHA) regulatory and corporate requirements.

● Developed and implemented a Total Quality System, led staff trainings and documented change management procedures.

● Successfully established an effective document control system and conducted detailed medical record reviews.

● Credited for developing and maintaining a purchasing and FDA compliant inventory control system.

PAST EXPERIENCE

ELKHART COUNTY GOVERNMENT, ELKHART, IN Jan 1994 – May 2001Chief Deputy Coroner

ELKHART GENERAL HOSPITAL, ELKHART, IN Oct 1996 – Jan 2000EMS Department Manager

INDIANA PUBLIC SAFETY TRANING INSTITUTE July 1990 – Jan 2000State Representative