Quality Professional
Resume:
Roger Crist
Quality Professional
ASQ® CMQ/OE, CQE, CSSBB, CQA, CMDA
ACMP® CCMP, Prosci® Certified
Email:
*******.****@*****.***
Mobile:
Address:
Saratoga Springs, UT
84045 USA
SUMMARY
• Experienced and effective quality professional
• Industries: Med Device, Aerospace, Automotive, General, etc.
• Standards: ISO 13485, AS9100, ISO/TS 16949, ISO 9001, etc.
• Former Lead Auditor for ISO Registrar; Certified to Current Standards
• ASQ Certified Quality Manager, Engineer, Six Sigma Black Belt, and Auditor / Med Device Auditor
• Coach/Mentor, Change Agent, Collaborator, Communicator, Quality Leader EDUCATION
Certificate / Degree College / University Completed Masters
Technology Management Brigham Young University Apr 1992 Bachelors of Science (B.S.)
Manufacturing Engineering Technology Brigham Young University Apr 1989 Certificate
Medical Device Manufacturing Salt Lake Community College Apr 2017 CERTIFICATIONS
Organization Certification Certified Since
American Society for Quality
(ASQ)®
Certified Medical Device Auditor (CMDA) Oct 2016
Certified Six Sigma Black Belt (CSSBB) Oct 2014
Certified Manager of Quality / Organizational
Excellence (CMQ/OE) Oct 1999
Certified Quality Engineer (CQE) Jun 1997
Certified Quality Auditor (CQA) Jun 1993
Association of Change Mgt
Professionals (ACMP)® Certified Change Management Professional (CCMP) Dec 2018 Prosci® Change Management Certification Oct 2019
EXEMPLAR GLOBAL CERTIFICATES
• ISO 13485-2016 Lead Auditor
• IATF 16949-2016 Lead Auditor
• ISO 9001-2015 Lead Auditor
AIAG CERTIFICATES
• Certified IATF 16949 Supplier Auditor
• VDA 6.3 Process Auditor Qualification
PROBITAS CERTIFICATES
• AS9100 Lead Auditor
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PROFESSIONAL EXPERIENCE
Company Position / Responsibilities From/To
Blackrock Neurotech
(Salt Lake City, UT)
QUALITY ENGINEERING MANAGER
• Ensured compliance to MDSAP / ISO 13485 requirements
• Implemented compliant and user-friendly quality processes using MasterControl To:
Apr 2025
To:
Jul 2024
U.S. Synthetic
(Orem, UT)
QUALITY DIRECTOR
• Supported strong culture of respect, kaizen, and lean manufacturing
• Implemented quality system best practices learned from a variety of industries To:
Jul 2024
From:
Jan 2023
Moxtek, Inc.
(Orem, UT)
QUALITY DIRECTOR
• Ensured compliance to all customer and regulatory requirements
• Supported quality planning for product development (APQP/PPAP)
• Emphasized preventive tools and a culture of quality
• Designed compliant and user-friendly quality processes using MasterControl
• Supported safety (i.e., IEC 60601) and regulatory (i.e., MDD/MDR, CE) compliance related to radiation-emitting electronic products
• Performed and documented risk assessments (ISO 31000/14971)
• Conducted internal and supplier audits to a variety of quality standards, regulatory and customer-specific requirements
To:
Oct 2022
From:
Jun 2009
Coca-Cola
(Atlanta, GA)
REGIONAL QUALITY SYSTEM MANAGER
• Supported 16 Coca-Cola bottling plants along the East Coast (NY to FL)
• Ensured compliance to FDA food safety requirements (cGMP, HACCP)
• Supported certification and integration of quality (ISO 9001), safety (ISO 45001), environmental (ISO 14001), and food safety (ISO 22000) management system standards
• Promoted from Northeast Region to new East Coast Region Manager To:
Jun 2009
From:
Jun 2007
MasterControl
(Salt Lake City, UT)
QUALITY, TRAINING, AND PROFESSIONAL SERVICES VP
• Managed quality system supporting compliance to FDA requirements
• Supported FDA-compliant software development life cycle (SDLC) including software quality testing and validation processes
• Supported design and testing of software validation toolkit (IQ/OQ/PQ) and validation services
• Performed training of customer IT and QA personnel prior to on-site configuration and training
• Performed process design to FDA and EU cGMP/cGCP/cGLP and GAMP 5 requirements for device, pharmaceutical, biologics companies (21 CFR Part 11, 50/56, 210/211, 312/314, 820 and EU MDD, ICH, etc.)
• Assisted in development of “Customer Success” culture and implementation of customer project management services
• Recipient of MasterControl “MVP” and “Masters Green Jacket” awards To:
Jun 2007
From:
Dec 1999
Weber State
University
(Ogden, UT)
Orion Registrar
(Arvada, CO)
Autoliv / Iomega
(Ogden, UT)
ASST. PROFESSOR, MANUFACTURING & MECHANICAL ENGINEERING TECHNOLOGY
• Taught manufacturing curriculum including Quality courses (Quality Management, DOE, etc.) and received Hemingway Faculty Vitality award for developing online quality course - performed Quality Audits and Consulting while teaching LEAD AUDITOR
• Lead Auditor on ISO 9001 and QS-9000 / ISO 16949 certification audits QUALITY ENGINEER / SUPPLIER QUALITY ENGINEER
• Performed Quality Engineering consulting for local companies including Autoliv
(automotive safety products) and Iomega (computer storage devices)
• Received recognition from Iomega for supplier quality corrective actions related to power supply, cables, and connectors project
To:
Dec 1999
From:
Jun 1996
RAM Company
(St. George, UT)
QUALITY MANAGER
• Implemented/maintained ISO 9001 / AS9100 customer requirements To:
Jun 1996
From:
Jun 1995
Berry Plastics
(Henderson, NV)
QUALITY MANAGER
• Led multi-site ISO 9001 certification and maintained cGMP
• Promoted from Quality Supervisor to Quality Manager To:
Jun 1995
From:
Jun 1992
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SKILLS
• Mistake-Proofing – poka-yoke (prevention)
• Continuous Improvement (CI) – process design, CI culture, employee involvement training, CI suggestions/projects (PDCA/Six Sigma), employee recognition/SWAG, CI Facilitation
• Continuous Improvement Methodologies – PDCA, Six Sigma/DMAIC, lean mfg, kaizen events
• Basic Quality Tools – cause & effect, check sheet, flowchart, histogram, pareto, run chart / SPC chart, scatter diagram / stratification
• Advanced Quality Tools – designed experiments (DOE), ANOVA, t-test, regression analysis, capability studies, MSA/Gage R&R, probability/statistical sampling plans, 10+ years using JMP software
• Risk Assessment – Design FMEA (DFMEA), Process FMEA (PFMEA), ISO 31000, ISO 14971
• Quality Planning – quality roadmap, quality objectives, contract review, key quality metrics
• Design and Development – process design, inputs/outputs, verification and validation / internal and external qualification, design reviews, change control, transfer to production, design quality into product/process, DFMEA / PFMEA, reliability requirements and testing, key product/process characteristics, control plans, drawings/specification review, APQP
• Supplier Quality – process design, supplier requirements definition and flowdown of key characteristics, supplier evaluation risk assessment / audits, supplier monitoring and re-evaluation / scorecards, part FAI/PPAP submissions, reviews, and approvals
• Root Cause Analysis – flowchart, five why’s, fishbone, fault tree analysis, data supported
• Problem-Solving – RCA, RCCA, 8D, corrective/preventive action (CAPA), PDCA, A3
• Quality Software Configuration / Validation – MasterControl software expert in Document Control, Training, Forms/Processes, AQEM (NCR, Customer Complaint, Deviation, CAPA, etc.), Supplier, Audit, and Risk modules/solutions (configured and validated dozens of life science quality systems to FDA requirements
• Other Quality Processes – internal audits, calibration, corrective action, nonconformance, customer satisfaction, document control / engineering change, management review
• Employee Training – training on quality culture and processes, mistake-proofing, RCA/corrective action, standardized OJT methodology (TWI), customer requirements, Six Sigma training (SSYB, SSGB, SSBB)
• Taught Manufacturing Courses at Weber State University including Designed Experiments, Quality Management, ASQ Certification Prep, Drafting, AutoCAD, Engineering Cost Estimating, Metal Forming, Casting, and Welding (hands-on Lab Instructor), Senior Project
• Customer Communications – key contact and facilitator for customer quality issues, quality reports, periodic quality review presentations, customer’ supplier surveys, and customer audits
• Export Control Compliance – ITAR/EAR controls, training, DPL screening, successful re-classification and license requests submitted to Dept. of Defense/Commerce
• Coach/Mentor, Change Agent, Collaborator, Communicator, Quality Leader FOREIGN LANGUAGE
• Portuguese (intermediate level reading, writing, and speaking)
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