Becky Brown

Becky Brown

Bio

Ms. Brown received a Bachelors of Science degree in Mechanical Engineering from Clemson University and a Masters degree in Quality Management from the National Graduate School of Massachusetts. She spent several years in quality and operations functions with Johnson & Johnson, managing the operations and quality engineering of Class I and Class III medical devices. Ms. Brown has also performed design and manufacturing quality functions supporting Class I and Class II medical devices with Kimberly-Clark, including four years as a mill quality management representative. She implemented and managed an ISO 13485/FDA compliant quality system supporting Class I and II devices for MedShape, Inc. as Director of Quality.

Because of her over 20 years in various roles within the medical device industry, Ms. Brown brings a strong background in quality system and regulatory compliance requirements as well as medical device manufacturing knowledge. She has served as SBME’s Director/VP of Quality since 2012 and more recently transitioned to the role of VP of Operations

Professional Services

Medical device quality management implementation and training consulting services for compliance to ISO 9001, ISO 13485, and FDA CFR requirements.

Equipment Setup

  • Setup lab equipment used to maintain and enhance product quality.
  • Setup production equipment used to permanently mark products with identification

Total Quality Management

  • Employee Involvement Teams, Work Place Instruction Teams, FMEA Teams, Quality Systems Improvement Teams, Workplace Utilization & Maximization Teams and ISO Auditing and Continuous Improvement Teams.
  • Completed AAMI Quality System Requirements and Industrial Practices Course
  • Completed AAMI Process Validation Course
  • Completed my Masters in Quality Systems Management
  • Obtained my ASQ Certified Quality Auditor certificate
  • Completion of OR Training (trained that allows one to view surgeries in an OR setting)
  • Completed ISO Lead Auditor Training
  • Completed Six Sigma Black Belt Training

Manufacturing Process Exposure

  • Injection Molding
  • Die Design
  • Assembly Equipment Design
  • Vertical and Horizontal Milling Machine Centers
  • Safety Issues
  • Workplace Instructions
  • Setup Reduction
  • Label Creation, Approval, and Production
  • Single and Twin Torret Lathes
  • Controlled/Sterile Packaging Environment
  • Huffman Grinding Centers/ Vertical and Horizontal milling centers
  • Robotic Deburring System
  • SCP and CMM Inspection Systems
  • Nonwoven Fabric Technology
  • Automated Face Mask, Drape, Apparel Machines

Product Exposure

  • PEEK (orthopedic implants)
  • Nickel Titanium (orhtopedic implants)
  • Kevlar (fire retardant)
  • Polyester Film (commercial and industrial)
  • Vectran (experimental)
  • Cloth (commercial and safety)
  • Nonwoven, polymer-based fabric (Spunbond, SMS, etc.)
  • Class I and III Orthopaedic Implants (patella, tibial inserts, etc.)
  • Class I Orthopaedic Instruments (cutting guides, tray trials, etc.)
  • Class III Perforator (cranial drill)
  • Class I and II Surgical apparel and barrier products (drapes, gowns, face masks, etc.)
  • Class II ACL and soft tissue fixation devices

Team Leader/Facilitator

  • Responsible for various teams and disciplines within organizations to improve the manufacturing aspects.
  • Facilitated from 5 to 50 associates in production and inspection settings.
April 2012
Secure BioMed Evaluations
VP of Quality
  • Quality System Design, Implementation, and Training
  • Supplier Audits
  • Process Qualification Support
Sept 2008
MedShape, Inc.
Director of Quality

Provide leadership to the company quality management functions to maintain compliance for Class II and CE Mark medical devices. Develop, implement and maintain an effective quality management system that resulted in the issuance of ISO 13485 certificate and CE certificate for bone anchors. Also resulted in successful baseline inspection conduct by the Food & Drug Administration an inclussion on FDA’s Medical Device ISO13585:2003 Valutory Audit SubmissionPilot Processor. Provide direction to quality functions to attain safety, quality, productivity, housekeeping, logistics, asset management, and human resource objectives. Mentor and develop less experienced associates. Manage equipment calibration, complaint handling, internal audit, management review programs, controlled environment certification, Supplier Management Program, and QC activities. Support Operations activities including device and instrument assembly and packaging (managed activities for a short time). Assist in the company’s design control, CAPA, and validation initiatives. Lead all FDA, ISO and other external audits.

June 2002
Kimberly-Clark Corporation
Quality Management Representative: June 2004 – Sept 2008

Provide leadership to the LaGrange Mill quality management functions to maintain compliance for Class II and CE Mark medical devices. Develop, implement and maintain an effective quality management system within LaGrange Mill that complies with all applicable requirements of ISO quality standards, specifically ISO 9001:2000, Food & Drug Administration Current Good Manufacturing Practices and Product Safety regulations. Provide direction to quality functions to attain safety, quality, productivity, housekeeping, logistics, asset management, and human resource objectives. Mentor and develop less experienced operations personnel. Manage the lab equipment calibration, complaint handling, internal audit, and management review programs. Drive the mill’s change control, CAPA, and process validation initiatives. Lead all FDA, ISO and other external audits.

QA Associate: June 2002 – June 2004

Support surgical and apparel businesses totaling approximately $400MM in sales.
Responsibilities include working effectively with the Regulatory Affairs, Sterility Assurance, R&D, Marketing, Manufacturing, Packaging, Mill QA/QC and other disciplines as may be necessary to support all design control activities for new products and change control activities for existing products and manufacturing processes. Support the business units in the resolution of any quality issues with existing products, manufacturing processes, or testing programs. Provide testing and compliance supports in the development and revision of raw material and finish product specifications. Interface with sales group and customers include creating and providing customer specifications and investigating and responding to customer complaints. Conduct quality systems assessments of suppliers, contract manufacturers, and internal manufacturing facilities. Issue and present timely quality reports and analyses to identify problems and opportunities for improvement based upon internal trending data and external product complaints.

July 2000
LifetecNet.com
Validation Manager

Responsibilities include creating validation protocols, engineering reports, and risk assessments using Microsoft Excel, Microsoft Word, and Visio for a web-based, Internet Explorer application for life science companies. Worked as liaison between development and FDA to ensure that all requirements complied with FDA guidelines. Performed manual tests on the application and used TestDirector to track any discrepancies found. Familiarized myself with SUN JAVA language to be able to read design code for testing. Used Visual Café and Quest Toad to verify code design and database requirements. Conduct audits on application functionality and configuration throughout the software life cycle. Managing the release of the application to the production environment. Created compliance requirements using Caliber and Dimensions, and used Microsoft Project to update the Compliance group’s activities. Also responsible for maintaining FDA compliance of application throughout its production use.

June 1996
Johnson and Johnson, Inc.
Quality Engineer/Team Leader: January 1999 – July 2000

Responsibilities include creating validation protocols, engineering reports, and risk assessments in compliance with regulatory guidelines for new and existing Class I and III products. Worked closely reviewing design drawings and requirements with R&D and Design Engineers to develop new orthopaedic and spinal instruments and implants and to ensure that all drawings and requirements complied with FDA and ISO guidelines. Conduct internal audits using ISO guidelines on processes throughout the facility. Also responsible for managing the base business and validation inspection done by the orthopaedic instrument quality assurance department, which consists of two quality inspectors, a lead quality engineering specialist, and two quality engineering specialists. Used MiniTab to analyze and manage a statistical process control project.

Manufacturing Facilitator/Planner: January 1998 – January 1999

Responsibilities include micro planning, facilitating, and quality controls for the production of Class I orthopaedic instruments. Also responsible for the quality and production of new product launches such as the inset patella and Depuy cutting guide projects.

Manufacturing Facilitator/Planner: June 1996 – January 1998

Responsibilities include planning, facilitating, and quality controls for the production of Class III perforator cranial drills and Class I and III orthopaedic implants and instruments. Also responsible for the setup and training of the Excel laser for etching purposes.

May 1994
Springs Industries
Manufacturing Facilitator

Responsible for several technical projects dealing with product enhancement. While in training, also assigned to facilitate a department on a back shift.

  • 1990 – 1994 Bachelor of Science in Mechanical Engineering, Clemson University
  • 1999 – 2001 Masters of Science in Quality Systems Management, National Graduate School
  • 2000 ASQ Certified Quality Auditor
  • 2006 Six Sigma Black Belt Training completion
P. C. Experience

Microsoft Excel, Word, Project, and PowerPoint, Visio, Microsoft Outlook, Internet Explorer, Lotus Notes, etc.

Becky Brown

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

(770) 837-2681

BBrown@SecureBME.com

800-361-0945

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