Lori Benson has over 30 years of experience in quality systems and regulatory compliance across numerous industries. She has expertise leading quality assurance, inspection, documentation, and supplier evaluation. Benson has worked in medical device companies where she improved quality systems, gained FDA compliance, and resolved regulatory issues. She is skilled in quality management systems, auditing, process improvement, and training.

1. Cellular: 909-455-7614 ▬ Lori Benson ▬ E-Mail: SpiritAsLori@gmail.com
Quality Systems Professional
Talented quality professional with over 30-year professional background leading all aspects of Inspection, certification, raw material
qualification and release, manufacturing, quality control, in process and final inspection, complaint analysis, CAPA and
nonconforming products, document creation, and document review and release of finished product, supplier control and evaluation
across numerous industries. Demonstrated expertise leading cross-functional teams and interdepartmental projects to implement
quality management systems and automate manual processes for enhanced efficiency. Experienced in quality systems, regulatory
compliance, and software implementation.
Accomplishments
• Extensive medical device company work on Corrective and Preventive actions (CAPA), nonconformances, Remediation, FDA
warning letters and consent decrees.
• Improved quality systems and regulatory compliance: Seven (7) Companies experienced FDA audits with Zero (0) 483
observations.
• Reduced product release time from eight days to zero (0) days reducing inventory and improving customer back order response.
• Project Leader for documentation improvement and paperwork error reduction team. Reducing documentation entry errors by
60% on one form alone.
Expertise/Skills
• Team Development and Mentoring • Management Consulting
• Quality Systems, Assurance and Control • Training
• Systems Implementations • Organizing
• Project Management • Planning
• Management Reporting and Analytics • Computer Applications
• Policy and Procedures Development • Statistical Analysis
• Cost Containment and cost reduction • Component Manufacturing
Professional Experience
Senior Compliance and Quality Consultant March 2015 to July 2016
Genesis Digital-Division of Carestream Health, CareFusion, Edwards Lifesciences
• Processing, review and closure of customer complaint files.
• Review of Factory Service and Failure Analysis Reports for inclusion of information in the complaint file. Remediation of Field
repair reports to include needed information.
• Correspondence with customer regarding complaint receipt as well as clarification of information.
• Processing of MDR (Medical Device Reportability.
• Internal Audits of the Quality Management System in Preparation for ISO 13485 certification.
• Writing and Modifications to Standard Operating Procedures.
• Consulting on handling of audit nonconformances and process improvements
• Review of complaint files and associated service records for reportability to US FDA and/or Competent Authorities in the EU.
• Completion of complex and changing reporting methods to client, including spreadsheets, summary reports and associated
reporting techniques.
• Working with client on internal audit CAPAs and process Improvement initiatives.
• Provide training on FDA regulations, CAPA and Root Cause Analysis.
Senior Compliance and Quality Consultant
Depuy Synthes West Chester, PA and Zuchwil Switzerland. September 2013 to February 2015
• Subject Matter Expert for the Global Remediation Quality Plan (GRQP).
• Member of an elite team High Impact Team, with the charter of going into areas with problems and solving them.
• Performed extensive legacy reviews for compliance with QSRs, ISO 13485, and company requirements for Environmental
Control, Sterilization, Sterile Water Systems, Pest Control, and Process Validations. Set high productivity standards.
• Wrote Comprehensive summary reports for reviews. Both for the sites, and Global levels.
• Assisted other reviewers in completion of checklists and summary report execution.
• Provided mock audit assistance to client personnel and feedback.
• Produced effectiveness monitoring plans for CAPA, and audit observations.
• Corporate Integrity Agreement (CIA) Training and Warning Letter remediation.
Director of Quality Assurance and Regulatory Affairs, Eagle Labs / Eagle Outsource
Rancho Cucamonga, CA September 2011 to June 2013
• Successfully brought in Four Multi-Million dollar clients from initial contact through full process and sterility validations.
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2. Cellular: 909-455-7614 ▬ Lori Benson ▬ E-Mail: SpiritAsLori@gmail.com
• Management of all Quality Personnel; including Document Control, Quality Engineering, and Quality Inspection functions.
• Writing, Planning and Execution of Sterilization validation processes for E-Beam, Gamma and Ethylene Oxide Sterilization.
• Supplier control and audits.
Quality Consultant April 2008 to October 2008 & February 2009 to September 2011
Technology Integration Group, Medical Technical Products, Terumo Cardiovascular Systems, Neutrogena and SQA Services
• CAPA Remediation and Closure. Large Team effort was a member of the core remediation and closure team.
• Full Quality System Audit to applicable standards and requirements: Including ISO 9001 and 21 CFR 211 Pharmaceutical cGMPs
and FDA Medical Device 21 CFR 820.
• Control of Certificates of conformance for shipments from OEM suppliers.
• Compilation of ADPR (Annual Drug Product Review) for OEM products. Statistical Analysis of ADPR Testing and graphical
analysis in Excel.
• Physical testing and inspection of Retain samples for ADPR reports.
• Established an ISO 9001-2008 QMS including; Quality Manual, objectives that are measurable and tied to the quality policy.
Quality Systems Manager
APEC, a Division of Helix Medical, Baldwin Park, CA October 2008 to February 2009
• Complaint Investigation and CAPAs.
• Established Training program and indoctrination program for all temporary and full time employees.
• Revised internal audit program.
• Established outgoing quality surveys.
• Managed document control and final product release.
Senior Quality Systems Audit Specialist and Document Control Manager
OneLegacy, An organ and Tissue Donation Organization, Los Angeles, CA March 2007 to April 2008
• Established controlled documentation for the donor chart process and established turnkey supplier for all Clinical Operations, to
ensure consistent and high quality transplant outcomes.
• Implemented and coordinated training program.
• Supported organization transfer to paperless (SmartSolve/Pilgrim) Electronic Quality Management System (EQMS).
• Performed Current Good Tissue Practice (cGTP) compliance audits for the Tissue Services operations.
• Lead and Senior Auditor.
Quality Consultant, SQA Services, Beckman Coulter 2004 to 2007
• Full Quality System Audits to applicable standards and requirements: Including 21 CFR.820 (QSIT) and, ISO 13485.
Documentation Supervisor, Abbott Laboratories, South Pasadena, CA 2001 to 2004
• Control of all documentation and design thereof.
• Change agent for documentation improvement/reduction team. Reducing documentation entry errors by 60% on one form
alone.
• CAPA Review Board (CRB) member.
• Control and Management of final product review and release.
• Responsible for monthly reports, metrics and dashboards for management review for department productivity and
documentation error reporting.
Presentations/Publications:
• ASQ Section Meeting, Multi-voting and brainstorming session.
• ISO-9001 v QSR Regulations – ASQ Section Presentation
• Affinity Diagramming Workshop – ASQ Section(s) Presentation
• Audit Checklists that add value – ASQ Section Presentation
Education
• Bachelor of Science
Training / Certifications
• Medical Device HACCP • Supplier Certification
• QSIT – FDA • Medical Device HACCP
• Validation • ISO 9001 QMS Lead Quality Auditor
• IRCA Certified QMS Auditor • ASQ CQA
Professional Associations
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3. Cellular: 909-455-7614 ▬ Lori Benson ▬ E-Mail: SpiritAsLori@gmail.com
• American Society for Quality (ASQ) senior member • ASQ 0702 Section Leadership 14+ years
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