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Andrew Rich Broomfield, Colorado 303-907-0309 ARich3@live.com
Education
Purdue University B.S. Neurobiology and Physiology 8/1993-12/1997
Post-Graduate studies in Exercise Physiology 1/1998-12/1999
Professional Experience
ProtoMED, Inc. Quality Assurance and Business Development 5/2009-10/2016
ProtoMED, Inc. is a small medical device company utilizing CAD/CAM and Rapid-Prototyping technology (Stereolithography)
to provide patient-specific anatomical modeling and surgical planning services for complex craniomaxillofacial surgeries.
o Directed a cross-functional team to develop the Quality Assurance program to meet and exceed
GMP, FDA 21 CFR 820, and ISO 13485 requirements using risk analysis and risk-based approach
o Wrote and edited each SOP to ensure FDA and ISO standards were met
o Successfully developed and implemented several process improvement programs
o Developed and implemented production machine validations, preventative maintenance, and troubleshooting
o Created and implemented a comprehensive employee training program. Acted as lead trainer.
o Developed and performed reliability and validation testing for existing and newly created processes and products
o Increased and maintained production yield to over 95% through root cause analysis, SPC, CAPA’s, and FMEA
o Developed and performed internal and external non-conformance procedures including product disposition
o Developed and performed in-process and final inspections using PPAP, and APAP, and GD&T techniques
o Conducted internal audits of the QMS on a regular basis
o Reduced and maintained customer non-conformances to less than 1%
o Developed and maintained a supplier quality program to ensure quality of incoming materials and resources
o As a supplier, worked with customers to develop product inspections to ensure customer specifications were met
o Manage surgical planning cases by coordinating with surgeons, medical staff, and technicians
o Successfully launched a new menu of products and services and grew sales by over 200% in the second year
Dynasplint Systems, Inc. Neurological Sales Consultant 9/2008-4/2009
Dynasplint Systems, Inc. is a medical device company that provides dynamic splints to improve joint
range-of-motion in orthopedic and neurological patients.
o Developed a new territory through direct-to-doctor/therapist/nurse contact
o Consulted with healthcare professionals to develop appropriate patient-specific treatment plan
o Custom fit Dynasplint devices to patients and conducted follow up appointments
City of Boulder Weight Training Coordinator 5/2007-9/2008
The City of Boulder provides 3 recreation centers each with a full offering of swimming, gymnasium, fitness classes,
gymnastics, and weight training.
o Managed a team of 15 personal trainers
o Created and implemented new health and wellness educational programs
o Requested and procured ~$100,000 budget for replacing and upgrading equipment and facilities
MountainWest Corporate Health Senior Program Manager 12/1999-10/2006
MountainWest provides health and wellness services including fitness center management, wellness seminars, health
programs, and fitness classes in corporate settings.
o Increased membership from ~700 to ~900
o Lead speaker for all educational seminars
o Created a company-wide inter-departmental competition that included endurance, problem solving, obstacles, and
teamwork

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ResumeAndrewRich

  • 1. Andrew Rich Broomfield, Colorado 303-907-0309 ARich3@live.com Education Purdue University B.S. Neurobiology and Physiology 8/1993-12/1997 Post-Graduate studies in Exercise Physiology 1/1998-12/1999 Professional Experience ProtoMED, Inc. Quality Assurance and Business Development 5/2009-10/2016 ProtoMED, Inc. is a small medical device company utilizing CAD/CAM and Rapid-Prototyping technology (Stereolithography) to provide patient-specific anatomical modeling and surgical planning services for complex craniomaxillofacial surgeries. o Directed a cross-functional team to develop the Quality Assurance program to meet and exceed GMP, FDA 21 CFR 820, and ISO 13485 requirements using risk analysis and risk-based approach o Wrote and edited each SOP to ensure FDA and ISO standards were met o Successfully developed and implemented several process improvement programs o Developed and implemented production machine validations, preventative maintenance, and troubleshooting o Created and implemented a comprehensive employee training program. Acted as lead trainer. o Developed and performed reliability and validation testing for existing and newly created processes and products o Increased and maintained production yield to over 95% through root cause analysis, SPC, CAPA’s, and FMEA o Developed and performed internal and external non-conformance procedures including product disposition o Developed and performed in-process and final inspections using PPAP, and APAP, and GD&T techniques o Conducted internal audits of the QMS on a regular basis o Reduced and maintained customer non-conformances to less than 1% o Developed and maintained a supplier quality program to ensure quality of incoming materials and resources o As a supplier, worked with customers to develop product inspections to ensure customer specifications were met o Manage surgical planning cases by coordinating with surgeons, medical staff, and technicians o Successfully launched a new menu of products and services and grew sales by over 200% in the second year Dynasplint Systems, Inc. Neurological Sales Consultant 9/2008-4/2009 Dynasplint Systems, Inc. is a medical device company that provides dynamic splints to improve joint range-of-motion in orthopedic and neurological patients. o Developed a new territory through direct-to-doctor/therapist/nurse contact o Consulted with healthcare professionals to develop appropriate patient-specific treatment plan o Custom fit Dynasplint devices to patients and conducted follow up appointments City of Boulder Weight Training Coordinator 5/2007-9/2008 The City of Boulder provides 3 recreation centers each with a full offering of swimming, gymnasium, fitness classes, gymnastics, and weight training. o Managed a team of 15 personal trainers o Created and implemented new health and wellness educational programs o Requested and procured ~$100,000 budget for replacing and upgrading equipment and facilities MountainWest Corporate Health Senior Program Manager 12/1999-10/2006 MountainWest provides health and wellness services including fitness center management, wellness seminars, health programs, and fitness classes in corporate settings. o Increased membership from ~700 to ~900 o Lead speaker for all educational seminars o Created a company-wide inter-departmental competition that included endurance, problem solving, obstacles, and teamwork