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Carolyn Tomlinson

Senior Director, QMS Training

Carolyn brings more than 30 years of quality system consulting, development, and management; quality system auditing; and quality engineering experience to each customer engagement.

Carolyn has worked with a wide range of medical device and pharmaceutical manufacturers to create, remediate, and optimize their QMS processes to meet the requirements of FDA regulations, EU MDR/IVDR, ISO 13485, ISO 9001, and other key international regulations and standards. In addition, Carolyn uses her expertise in quality systems training and auditing to help clients effectively implement their QMS processes, review them through internal audit programs, and present and defend them in inspections and audits.

Carolyn at a Glance

Audit Expertise

  • 21 CFR 820, 803, 806
  • 21 CFR 211
  • ISO 13485
  • ISO 9001
  • ISO 17025
  • Supplier Audits

QMS Process Expertise

    • QMS Implementation
    • CE Marking Technical Documentation
    • ISO 14971/Risk Management
    • Management Responsibilities
    • Change Management
    • ISO 14971/Risk Management
    • Supplier Quality
    • Production & Process Control
    • Aseptic Processing
    • Sterilization (Gamma, ETO)
    • Resource Management
    • Document Control
    • FDA Inspections and Remediation
    • NB Audits and Remediation
    • Postmarket Surveillance
    • Internal Auditing
    • Complaint Handling and Investigation
    • CAPA


  • Bachelor of Science, Chemical Engineering, Virginia Tech


  • ISO 13485 & ISO 9001 Lead Auditor
  • MDSAP Internal Auditor
  • ASQ Certified Six Sigma Black Belt
  • ASQ Certified Quality Engineer
  • ASQ Certified Quality Engineer
  • ASQ Certified Quality Auditor

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Carolyn’s Areas of Expertise

  • Quality Management Systems – Has created, implemented, managed, and remediated QMS processes compliant with ISO 13485, ISO 9001, FDA 21 CFR 820/211, Canadian MDR, EU MDR/IVDR, and more.
  • Auditing – Has conducted internal and supplier QMS audits; hosted Regulatory Authority inspections, and Notified Body and customer audits; managed internal and supplier audit programs; and trained new internal and lead auditors.
  • Training – Has created and delivered engaging and effective in-person and virtual, instructor-led training for a variety of QMS topics, including auditing, supplier quality, risk management, NC/CAPA, root cause analysis, and overall QMS requirements, among others.

Highlighted Experience

  • Led EU MDR transitions for multiple clients, including product technical documentation and QMS process creation and updates for compliance with new and changed regulatory requirements, MDCG guidances, and Annex XVI Common Specification requirements.
  • Managed front- and back-room operations for multiple FDA facility inspections of an aseptic processing manufacturing site forsterile contact lens solutions and OTC ophthalmic products under 21 CFR Part 820 and 21 CFR Part 211 regulations. Also, managed all Notified Body and customer (private label manufacturing) audits to ISO 13485 and ISO 9001 for the same facility.
  • Led the mitigation of a warning letter and multiple Form 483s to successful conclusion for clients through effective root cause analyses and CAPA planning and execution.
  • Led the development, implementation, and ongoing management of the quality management system for two start-up manufacturing facilities.
  • Served in leadership roles for multiple manufacturing facilities ($10 million to $300 million revenue) with responsibility of all aspects of the QMS and management of QA teams with 2 to 60-plus employees.
  • Developed a standardized data collection system for product and supplier nonconformance information, and redesigned the supplier nonconformance process to improve its effectiveness and efficiency.


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