Saundra Naughton

Saundra Naughton

Bios

Saundra Naughton, Quality Consultant

Ms. Naughton joined in January 2017, bringing with her over 15 years of experience in quality assurance, process engineering, and project management in textiles, consumer products, and medical device industries. Additionally, Saundra has experience in research, product, and test method development, having actively contributed to several patents for product design and intellectual property. Throughout her career, Saundra has been instrumental in establishing new quality systems, launching new products to market, and improving workspace utilization/ efficiency.

Having an industrial engineering- based background,Saundra is very process-focused and hands-on in finding create solutions that are grounded in the science of human factors.

Services

Saundra contributions are primarily in Quality Systems Management/ Quality Assurance.

Operations
  • Production/ Equipment Scheduling
  • Maintaining Facility OSHA/ EPA compliance
  • System administrator for ERP/ CRM software
  • Supply chain management for multiple strategic partners
  • Train and mentor Customer Service/ Lab Technicians
  • Hire, train, and supervise QC Inspectors
Quality Engineering/ Process Engineering
  • Analyze sales data for production forecasts and schedules
  • Create and analyze system ad hoc reports for Sales and Operations
  • Create monthly complaint data analysis reports
  • Maintain production and quality metrics data
  • Initiate and lead continuous improvement projects, with focus on error-proofing, increasing efficiency, and eliminating waste
  • Execute manufacturing process and equipment validations
  • Create procedures, work instructions, and process specifications
Quality Assurance
  • Conduct process, supplier, and internal audits
  • Maintain/ manage document and records control
  • Perform non-conforming material, complaint, and corrective/ preventive action investigations
  • Lead compliance audits with customers, FDA, and notified bodies
  • Maintain sterility assurance program
  • Create/ administer training programs
Research and Development
  • Design and perform laboratory experiments, collect/ analyzed data, and issue technical reports
  • Design/ develop/ validate new test methods and procedures
  • Evaluate existing competitor patents and develop new patents
  • New product development, prototyping, testing, and validation
Project Management
  • Project lead for manufacturing, contractors, and suppliers in support of product launches, product improvements, and process changes
  • Project manager for competitive product testing studies
  • Project lead for ERP/CRM software implementation and deployment
Industries/ Products
  • Pharmaceutical dispensers
  • Surgery/ procedure convenience kits (EO sterilized)
  • Orthopedic devices
  • Disposable diapers/ training pants/ adult incontinence pants
  • Textiles- wovens for industrial/ consumer product
  • Textiles- fire protection fabrics
DoseLogix
Total Quality/ Supply Chain Manager. 2014

Responsible for managing/ coordinating operations activities among contracted manufacturers, warehousing/logistics partners, customer service, and sales team to ensure inventory balance and on-time delivery. Provide technical product support to pharmacies. Manage projects for new product development and continuous improvement initiatives. Implement and manage ERP and CRM systems. Provide technical expertise in design, prototyping, testing, and deployment of new products and improvements. Direct weekly project management and operations meetings.

MedShape, Inc.
Quality Assurance Associate. 2011

Responsible for performing QC inspections for incoming, in-process, and final product releases. Maintain document control and training records. Provided quality support in new product development activities and process validations.

Stradis Healthcare
Quality Assurance/ Regulatory Affairs Manager. 2002-2004, 2005-2011

Responsible for implementation and maintenance of all components of cGMP compliant Quality Management System: CAPA, complaint handling, hosting/ performing audits, sterility assurance, production control/ process validation, document control/ records management, training. Initiated/ lead continuous improvement projects. Manage projects for contract customers. Manage/ mentor QC associates. Support Operations and Sales as needed.

Chart Industries
Quality Engineer, Bio-Medical Division. 2004

Responsible for providing technical assistance with start-up of a new production facility/ relocation of an existing product production line. Ensure successful and timely re-certification of product line at the new location. Hire, train, and supervise QC inspectors. Oversee warranty returns. Perform process audits. Investigate non-conformances.

Paragon Trade Brands
Associate Quality Engineer- Corporate. 2001

Responsible for document control system management, providing on-site quality technical support for manufacturing process validations and new product launches, create monthly complaint data analysis reports.

Advanced Materials Development Technician II. 2000

Responsible for performing laboratory experiments and issuing technical reports, developing new test methods and procedures, reviewing competitor patents, validating test results, and developing new patents.

Milliken & Company
Process Engineer/ Environmental Specialist. 1998

Responsible for leading Focused Improvement Project Teams and Quality Maintenance Program, writing/ revising machines specifications, leading facility OSHA/ EPA compliance program, daily management of quality and efficiency on assigned product lines, machine scheduling.

  • Master of Science, Systems Engineering- Decision Modeling. Kennesaw State University, 2016.
  • Bachelor of Science, Textile Engineering. Southern Polytechnic State University, 1998
Saundra Naughton

7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188

(770) 837-2681

800-361-0945

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