Sarah Lacey Robbins

Quality Manager at Rook Quality Systems
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Contact Information
us****@****om
(386) 825-5501
Location
Charlotte, North Carolina, United States, US

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Credentials

  • Certified Quality Management System Lead Auditor
    Oriel STAT A MATRIX
    Jan, 2020
    - Nov, 2024
  • QMS Training for Medical Devices: FDA QSR and ISO
    Oriel STAT A MATRIX
    Nov, 2018
    - Nov, 2024
  • Regulatory Affairs Certification (RAC)
    Regulatory Affairs Professionals Society (RAPS)
    Dec, 2022
    - Nov, 2024
  • Adult First Aid/CPR/AED
    American Red Cross
    Aug, 2019
    - Nov, 2024
  • Bloodborne Pathogens
    American Red Cross
    Aug, 2019
    - Nov, 2024

Experience

  • Rook Quality Systems
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Manager
      • Sep 2021 - Present

      • Provides regulatory and quality consulting to various clients within the medical device industry in order to achieve compliance with applicable regulations and standards (21 CFR Part 820, EU MDR 2017/745, MDSAP, SOR/98-282, ISO 13485:2016, ISO 14971:2019, and IEC 62304:2014). • Represents and assists clients with ISO and regulatory audits. • Performs internal audits of clients’ quality management systems to ensure compliance with application regulations and standards. • Complies and reviews Design History Files, Risk Management Files, Medical Device Files, and Technical Files for various medical devices based upon client needs. • Implements Quality Management Systems for medical device designers and manufacturers. • Assists clients with complaint investigations, corrective and preventive action implementation, audit responses, validations, and personnel training.

  • HARTMANN GROUP
    • Germany
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality Manager
      • 2017 - Jul 2021

      • Ensured that the organization's Quality Management System (QMS) conforms to regulatory requirements per FDA 21 CFR 820.• USA representative for Global Audit Management Team for internal and supplier quality management; certified ISO 13485:2016 Lead Auditor.• Oversaw Product Lifecycle Management (PLM) and Change Control Management (CCM) processes for USA division pre- and post-market activities for all FDA and globally registered products.• Participated in 510(k) product submissions and product risk assessments for 21 CFR 820 Class I Sterile medical devices.• Participated on the Global Corrective Action, Preventative Action (CAPA) team; oversees USA division.• Oversaw Quality and Regulatory Budgets for USA division.• Reported to top management on the performance of the QMS key performance indicators (KPI), including the need for improvement.• Oversaw USA post market surveillance division for customer related complaints.• Led 43 quality-assurance projects and enhanced productivity: 93% increase in cost savings.

  • Chem-Bac
    • Chemist
      • 2016 - 2017

      • Ensured bacteriological and analytical testing on environmental, pharmaceuticals, and petroleum samples were performed according to standard procedures.• Coordinated and performed analytical testing for petroleum products using ASTM and MV-FUEL-160 testing methods. • Ensured bacteriological and analytical testing on environmental, pharmaceuticals, and petroleum samples were performed according to standard procedures.• Coordinated and performed analytical testing for petroleum products using ASTM and MV-FUEL-160 testing methods.

  • CoaLogix
    • United States
    • Environmental Services
    • 1 - 100 Employee
    • Analytical Chemist
      • 2015 - 2016

      • Engaged in research activities to develop innovative catalyst regeneration technologies and identify new opportunities and application methodologies.• Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.• Repaired, calibrated and safely operated laboratory equipment to reduce costly instrument downtime. • Engaged in research activities to develop innovative catalyst regeneration technologies and identify new opportunities and application methodologies.• Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.• Repaired, calibrated and safely operated laboratory equipment to reduce costly instrument downtime.

Education

  • Winthrop University
    Bachelor of Science - BS, Chemistry
    2010 - 2015

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