John Naylor has over 15 years of experience in quality management and assurance roles. He is currently the Quality Manager at Wi Inc. where he manages their ISO 13485 certified quality system and represents them in audits. Previously, he worked as a Quality Assurance Engineer at Vital Signs Inc. where he conducted audits, coordinated corrective actions, and validated testing systems. He has also held roles as a Calibration Technician and Supervisor in the U.S. Navy where he calibrated over 600 gauges and supervised nine technicians.

1. John Naylor
14767 E. Temple Dr. Aurora, CO. 80015
720-416-0337 / naylorfabian@gmail.com
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EXPERIENCE
Quality Manager 09/2013-Present
Wi Inc., Englewood, CO.
 Manage Wi’s ISO 13485 certified quality system and represent Wi for ISO and customer audits.
 Meet with project teams on progress, compliance, design reviews and risk analyses.
 Control external standards, quality, project and training documents.
 Manage internal audit team, schedule, reports and CAPA actions resulting from audits.
 Organize CAPA Boards, ECN Boards and quarterly Quality Management Reviews.
 Perform and maintain calibration and preventative maintenance systems for equipment.
 Write, train and execute documents for processes; IQ, OQ, PQ, Gage R&R, PFMEA, DFMEA,
Protocols, SOPs, WIs, Project PERT, Gantt and Org Charts.
 Contact suppliers and customers to address and correct quality issues.
 Manage QC personnel and daily project quality tasks.
Quality Assurance Engineer 08/2007- 08/2013
Vital Signs Inc., Englewood, CO
 Conducted process, product and system quality audits and coordinated CAPAs to resolution.
Scheduled and maintained the internal audit system.
 Assisted with FDA and 3rd party audits of the QMS for compliance to FDA, cGMP, ISO and CSA
regulations.
 Coordinated MRB and RGA with suppliers and utilized risk management to determine the impact to
patient safety. Presented quality trending to management.
 Used Six Sigma DMAIC and other quality principles to identify root causes of problems and promote
quality improvement.
 Reviewed technical files and dossiers to evaluate if products meet standard changes and customer
requirements.
 Performed IQ, OQ and PQ of equipment, components and materials and collaborated with
engineering, production and management to develop SOPs, OIs and other governing
documentation.
 Managed the product repair system, oversaw documentation, investigation, testing and customer
complaints.
 Validated three electronic test systems, one decreased inspection time by 40%, the 2nd
decreased inspection time by 35% with a savings of $2,000/month and the 3rd detected
breached material in the molding extrusion process during production therefore saved time and
material.
 Validated a new SPC system, built the database and performed analysis that trends component
data.
 Skilled in technical writing, summary presentations and Microsoft office programs.

2. John Naylor
14767 E. Temple Dr. Aurora, CO. 80015
720-416-0337 / naylorfabian@gmail.com
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Calibration Technician 06/2006 - 08/2007
Vital Signs Inc., Englewood, CO
 Performed company metrology and calibration functions of over 600 gauges and equipment
traceable to NIST.
 Trained Q.C. inspectors in measurement techniques and instruments which decreased variation.
 Assembled and repaired certified electro-medical equipment and represented VSD during by
CSA audits.
 Drafted a proposal contrasting renting vs. buying scales for quarterly inventory saving VSD
$1,060/yr.
 Removed 32 obsolete or redundant gages that saved 24 calibration hours and $3,800 annually.
Photographer 06/2005 - 06/2006
J. Naylor Photography, Denver, CO
 Managed a ‘Studio to You’ concept that offered family, pet, senior portrait and model type
services.
Electronic Calibration Work Center Supervisor, 09/1995 - 04/2005
U. S. Navy, PHNSY
 Supervised nine technicians that conducted electronic instrument inspections and certifications
onboard U.S. submarines, performed component level repairs and saved the Navy $275,000 in
replacement costs.
 Organized inventory distribution for 434 gages valued in excess of two million dollars, solved
logistical deficiencies, instituted policies and programs improving equipment readiness from 85%
to 97%.
 Developed a training program increasing the promotion rate 48% consequently adopted by
other divisions.
EDUCATION
ISO 13485, ISO 9001 Certified Lead Auditor - RABQSA, 2009
M.S.A. General Administration, Central Michigan University, 2005
U.S. Dept. of Labor Electronics Tester Journeyman’s License, 2005
B.S. Occupational Education, Wayland Baptist University, 2003
U.S. Navy GPETE Calibration and Maintenance School, 2002