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Principal Quality Systems Consultant at NAMSA Clinical & Consulting

Lezlie Hynes, MT (ASCP), CQA, CSQE

Principal Quality System Consultant

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Lezlie has over 30 years’ experience in the fields of medical device, INVD, HCT/P and hospital and reference laboratories. She has been with NAMSA since 2010, where she has gained experience working on various

standards committees and working groups, in addition to partnering with international Clients—from small start-ups to large corporations—to develop and maintain quality systems and bring products to market. A special focus has been working with Sponsors to implement and validate computerized systems and assist in product development for Software as a Medical Device (SaMD) and SiMD products.


  • Develops, manages and maintains operational Quality Management Systems (QMS)
  • Conducts internal, supplier and third-party audits and QMS Gap Assessments measured against:
  1. 21 CFR Parts 11, 50, 54, 58, 803, 806, 812, 820, 1271
  2. ISO 13485:2016, 14971:2019, 14155:2020, 9001:2015, 19011:2018, 17025:2017
  3. EU MDD, EU MDR and multiple country-specific regulations
  4. IEC 62304 and 82304-1
  • Supports Client FDA inspections and Notified Body assessments
  • Provides GMP, QSR and inspection readiness training; conducts mock FDA inspections
  • Assists Sponsors with remediation of audit and inspection findings
  • Provides QMS support for regulatory submissions
  • Conducts supplier qualifications and ongoing audits of Electronic Data Capture (EDC) system providers for clinical trials
  • Implements and validates various computerized software systems, including Electronic Quality Management Systems (eQMS), labeling and SPC software, Electronic Trial Master File (eTMF) and SharePoint


  • Provided Quality System support for a Client’s successful PMA submission
  • Assisted Sponsors with implementation and validation of eQMS software applications, meeting go-live date goals
  • Provided on-site support for a large Client’s FDA inspection