Scott Laman

Experience

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  ASQ - World Headquarters

  Jan 2001 - Jan 2024

  ASQ Leadership Positions

  Chair, ASQ Quality Press Peer Review Committee 1/24 - present• Led strategic initiatives to fill the Quality Press pipeline with the best books on Quality-related topics.Chair, ASQ Professional Ethics and Qualifications Committee 2/12 – 5/19• Developed the current ASQ Ethics Policy. Developed, implemented and executed an improved process to resolve ASQ member issues with ethical implications. Chair, ASQ Certification Board 7/10 – 12/12 • Developed a comprehensive documentation quality system encompassing all procedures and forms.Quality Progress Editorial Review Board 1/19 - presentSME, ASQE Risk Management Specialized Credential & eLearning development 1/21 - 12/21Chair, Certified Biomedical Auditor Exam 1/14 – 12/16Past Chair, Certification Board 1/13 – 12/16Voting Member, ANSI-Accredited U.S. Tech. Adv. Group on Quality Mgmt. and QA 6/12 – 12/16Reviewer of technical presentations, World Conference on Quality and Improvement 5/15 - presentModerator for technical sessions, World Conference on Quality and Improvement 5/15 – presentLead Judge, PAR Innovation Award 1/15 – 12/16Member, Lancaster Medal Award Committee 1/16 - presentVice Chair, Certification Board 7/08 – 6/10Chair, New Exams 7/05 - 6/08• Certification Board Excellence Award - May 2006, "In recognition of your vision and creativity in improving the certification board organizational structure and processes"Chair, Certified Reliability Engineer Exam 2/03 - 6/05• Certification Board Excellence Award - May 2004, "In recognition of your leadership, guidance and enthusiasm in articulating the value of certifications for the Certification Board"Exam Development Workshop Volunteer 2/01 - present (24 Exam development workshops) Show less

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  Teleflex

  Jan 2008 - Jan 2024

  Represented organization in FDA and notified body audits as the Quality Management Representative. Ensured the 140-person design center QMS was implemented and maintained to meet global standards and regulations. Served as Global SME for risk management, statistical techniques, post-market surveillance, CAPA / nonconformance, design and production control, and quality engineering / quality assurance. Managed suppliers that provided products and services to research and development (R&D) and laboratory operations.• Implemented training and improved monitoring, boosting on-time nonconformance responses from 50% to 100%. • Trained and certified internal auditors, which increasing the number of qualified auditors by 50%. • Implemented the site’s first Management Review, CAPA, and Quality Objectives, yielding 100% on-time compliance versus timeliness and target levels.• Led notified body audit that resulting in 0 nonconformances and quality system recertification.• Conducted 3 Design Transfer Readiness Assessments at manufacturing sites, verifying R&D’s essential design output implementation in the manufacturing controls.• Received Living Quality Award for the site’s performance in implementing strategic quality initiatives. Show less Established, improved, and maintained global systems for ISO 14971 risk management, quality / reliability engineering, statistical techniques, and post-market surveillance. Created and implemented global technical training programs including assessments to verify effectiveness of training. Directed highest levels of quality engineers and Project Management function of Global Design Assurance.• Defended organization in for-cause FDA audit related to Class 1 recalls, leading to no further action taken by FDA. • Cultivated best practices by creating and administering global technical training programs for ISO 14971 risk management per MDR, including linkages to post-market surveillance and clinical, and statistical techniques.• Developed process to trace identification of essential design outputs through design control and manufacturing implementation, leading to successful design transfers.• Created content for ASQ on-line training courses, including Six Sigma Yellow Belt, Six Sigma Green Belt, RM Specialized Credential, and CQE Live, applying knowledge gained to Teleflex’s internal training strategies. Show less Executed multi-site leadership responsibilities as Management Representative and Person Responsible for Regulatory Compliance. Oversaw 20 Quality Engineering and Quality Assurance personnel. Created objectives and reported on supplier performance, quality metrics, CAPA / Nonconformance, and internal / external audits. Represented organization in MDSAP, MDR, and Biocompatibility / Sterility notified body audits.• Led Risk Management Workstream for EU MDR implementation, including gap analyses and action plans, providing compliance by MDR implementation deadlines.• Implemented MDR risk management systems supporting post-market surveillance planning and reporting, PSUR, human factors and usability engineering, labeling, IFU, and hazardous materials.• Performed gap analysis and upgraded global risk management system to ISO 14971:2019, ensuring continuing compliance to latest standard.• Created and documented FMEA-based approach to quality system process risk management, delivering risk analysis and innovative, compliant process to use for audit defense.• Spearheaded organization-wide ASQ Certified Quality Engineer training for 30 candidates across six sites, improving the organization’s capabilities in all areas of quality engineering. Show less Executed strategic leadership responsibilities as a member of Vascular Leadership Team, reporting to business President. Hired, developed, and managed Quality Managers and Engineers across 4 sites and business units. • Strengthened influence and depth and breadth of contributions by growing Vascular Quality Engineering team from 4 to 22 people supporting new product development, sustaining engineering, post-market surveillance, compliance / MDR, and quality assurance.• Provided uniformity by creating global Quality Engineering job descriptions, career paths, and competency requirements.• Completed continuous improvement projects with Strategic Sourcing and Sustaining Engineering, optimizing quality, cost, and risk of supplied components. • Conducted value-added supplier quality audits, enabling business decisions and ensuring supplier quality.• Performed proactive internal audits, identifying issues and leading to successful notified body audits.• Ensured compliance by implementing initial ISO 14971 processes and procedures for risk management, statistical techniques, issue / event-based risk assessments, and HHE per ISO and FDA requirements. • Increased in-house intellectual property by administering corporate training in root cause analysis and problem solving for CAPA, risk analysis and management, statistical techniques, test method validation, and best practices in design control.Previous Teleflex Roles: Senior Manager, Global Quality Systems; Manager, Quality Engineering; Senior Quality EngineerAdditional Professional Experience:Quadrant Engineering Plastic Products, Reading, PA - Principal Process Development Engineer, Senior Quality EngineerThe Dow Chemical Company, Midland, MI - Senior Research Engineer Show less

  • Site Quality Director

    Jan 2024 - Jan 2024

  • Director, Global Design Assurance Systems

    Jan 2023 - Jan 2024

  • Site Quality Leader (Site Head of Quality, QA/QE, 165-person Technical Center)

    Jan 2021 - Jan 2024

  • Sr. Manager, Quality Engineering and Risk Management

    Jan 2008 - Jan 2021
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  Laman Quality Consulting, LLC for multiple organizations and industries

  Jan 2025 - now

  Quality Consultant/Auditor

  Perform internal and supplier audits. Provide value-added advice and solutions for quality system improvement and remediation. Create on-line training material for certification exams.