Ross D. Smith

Senior Director, Quality and Compliance at Ken Block Consulting
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Contact Information
us****@****om
(386) 825-5501
Location
Keller, Texas, United States, US
Languages
  • English Native or bilingual proficiency
  • Spanish Professional working proficiency

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5.0

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Eric McFarland

I can't thank Ross enough for all lessons, tips and techniques he taught over the course of ~6 years (3 reporting directly) that I carry with me today! Ross is an exemplary leader whom I still look up to. He has high emotional intelligence with an innate ability to coach others, inexorably improving that which he touches. He's data-driven, hard-charging, and raises up all those around him as a fountain of knowledge and ideas. I would recommend Ross as a leader and teammate to any organization: it will improve, engagement will rise, and folks will enjoy themselves in the process. I personally hope I haven't exhausted the lessons he surely still has to offer, and look forward to our paths crossing again. Please don't hesitate to contact me with any questions.

Lisa Marie Smith

I worked directly with Ross for five years. He was a member of the steering committee that designed and implemented an enterprise-wide quality system operating framework, and responsible for acting as liaison and coordinator of process standardization across multiple diverse businesses within the company. He always demonstrated superior engagement and commitment, through challenges and change, to ensure the voice of his customers and the success of the initiative. His systems thinking and detail orientation were critical to the delivery of superior technical and process integrity, and robust organizational change management. His calm, level-headed approach inspired the same in others and helped the team stay true to guiding and operating principles. I would welcome any opportunity to work again with Ross, and highly recommend him to others.

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Credentials

  • Certified Six Sigma Black Belt (CSSBB)
    ASQ - World Headquarters
    Mar, 2009
    - Nov, 2024
  • Certified Quality Improvement Associate (CQIA)
    ASQ - World Headquarters
    Dec, 2007
    - Nov, 2024
  • Certified Quality Engineer (CQE)
    ASQ - World Headquarters
    Jun, 2007
    - Nov, 2024
  • Lean/Sigma Black Belt
    Air Academy Associates
    Jul, 2006
    - Nov, 2024
  • Lead Auditor - ISO 9001 & ISO 13485
    AQS Management Systems
    Apr, 2004
    - Nov, 2024

Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Director, Quality and Compliance
      • Aug 2023 - Present

      Lead quality and compliance activities for comprehensive medical device consulting strategies. Drive projects and priorities for clients around the globe to deliver business performance. Lead quality and compliance activities for comprehensive medical device consulting strategies. Drive projects and priorities for clients around the globe to deliver business performance.

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Head of Global Compliance & Audit
      • Feb 2022 - Jun 2023

      Led global compliance and audit programs to identify compliance concerns that drive enterprise risk reduction. Operations included more than 70 facilities on 4 continents, with team members across multiple international locations. Scope focused on global compliance improvement, audit program performance, mergers & acquisitions, and enterprise compliance risk management. - Developed and deployed formal Quality Audit Program structure - Improved enterprise risk management, data analytics and external compliance risk measures - Enhanced global procedures and processes for internal and external audit management Show less

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Director, Quality and Compliance
      • Apr 2021 - Feb 2022

      Led quality and compliance operations for comprehensive medical device consulting strategies. Drove projects and priorities for clients around the globe to deliver business performance. - Developed FDA and ISO compliant quality system structure for international companies- Established and implemented multiple quality systems for clients scaled to their business- Improved quality systems for multiple clientele to ensure compliance and efficiency

    • Senior Consultant
      • Dec 2020 - Apr 2021

      Led and executed important client projects including quality system strategy, implementation, and compliance. Projects included process design and process improvement on devices from sterile products to electro-mechanical instruments.

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Group Sr. Quality Systems Manager, RTG
      • Oct 2016 - Oct 2020

      Established strategy to standardize the Quality System in Restorative Therapies Group, working across 30 international locations and multiple Medtronic businesses. Manage projects over 5-year horizon to improve business performance and cross-site collaboration through strategic initiatives.- Reduced quality system procedures across Group by 20% in one year- Developed quality system governance model and deployed across organization- Saved $2.2M in annual maintenance and process costs in 3.5 years Show less

    • Division Sr. Quality Systems Manager at Medtronic
      • Dec 2013 - Oct 2016

      Established division Quality System harmonization strategy across 8 locations. Managed projects over 3 years that improved overall business performance and ability to effectively collaborate across locations.- Developed and implemented Division Quality System strategy and roadmap- Planned and led >60 projects in 3 years to drive quality system efficiencies and compliance- Program savings of $1.4M annually

    • Division Sr. Supplier Quality Program Manager
      • Nov 2011 - Dec 2013

      Established supplier quality harmonization strategy for Division, driving supplier quality program at 10 international locations to improve effectiveness and efficiency. - Enhanced supplier performance through strategic initiatives across division that improved onboarding, material qualification/inspection, metrics/KPIs, auditing and corrective action processes- Implemented supplier certification program to improve quality and reduce inspection costs- Transformed supplier controls to avoid compliance risks resulting in successful FDA inspections Show less

    • Quality Manager
      • Apr 2008 - Nov 2011

      Managed quality teams for supplier quality and final product inspection at Fort Worth location, while improving supplier quality performance through development and partnership initiatives.- Reduced waste by 25% from batch inspections through implementing process flow improvements - Reduced recurring manufacturing nonconformances by 28%- Managed 15-person QA team at Fort Worth location, including development and recognition

    • Senior Quality Engineer
      • Jul 2006 - Apr 2008

      Led improvement efforts to ensure regulatory compliance of the quality system at Fort Worth location, and improve overall quality performance. - Drove project to implement new injection mold and establish stable process capability- Eliminated customer complaints and reduced handling costs by 27% by re-designing packaging- Led Six Sigma project to eliminate product testing waste saving $150K annually

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Quality Manager
      • Jul 2003 - Jul 2006

      Led quality team for product release and quality system compliance, while serving as the Management Representative. Teams responsible for calibration, customer complaints, document control, sterility assurance, supplier quality, QC Labs and quality engineering. - Improved customer complaint process and reduced complaints by 27% annually - Established best practices for internal audit, CAPA and NCR programs - Managed 40-person quality team at Fort Worth location, including team and individual development Show less

Education

  • University of Phoenix
    Bachelor of Science, Business Management

Community

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