Document Control Manager, Technical Writer, Records Management

KENNETH ENSELL

11805 Easy St                                                                               512-520-7309                                                                                                          
 Austin, Texas 78748                                                           ensellk@yahoo.com   

                   

   ~   Expertise Developing & Implementing Effective Document and Record Retention Programs, Writing                                              
       and Releasing a Wide Range of Technical and Easy to Understand Documents.
 
      Each Task Completed has a Beneficial Ripple Effect throughout the Organization  ~  
 

PROFILE SUMMARY

20 years’ experienced Document Control Manager with extensive Quality Systems knowledge. Developed, wrote and released documents in accepted formats for quality systems documents and projects in high tech and diverse environments. Responsible for controlling all types of documents, monitoring revision changes using ECNs and leading Change Control Board meetings. Ensured all documents including drawings, met Corporate, Industry and Regulatory Standards. Strategic decision maker able to communicate and be a team player supporting functional teams. Designed and populated innovative Disaster Recovery Room, garnering major efficiency gains, including the smooth transfer of records. Managed a staff of 5 for document control and monitored 15 technicians for calibration actives in test labs  

Keywords   

Manager Document and Archive Control • Prolific Writer for Various
Types and Styles of Documents • Change Control and ECNs • Crafting Disaster Proof Room
for Records • Proofreading and Editing • Analytical Problem Solving •
Continuous Improvement • Staff Training • Internal Audits, Proficient Equipment
Knowledge • ISO, SOX, QS, FDA, GMP Compliance • Computer Savvy • Strong
Organization, Facilitation, Interpersonal, and Leadership Skills

PROFFESSIONAL EXPERIENCE

ST. JUDE ADVANCED MODULATION SYSTEMS, Plano, Texas--2010 Manufacturer and Distributor of
cutting-edge Spinal Cord Stimulation Systems

Project Manager

  • Reviewed documents and records to determine what plan to follow for corrective and preventative action.  Subject Matter Expert (SME) performing investigation into root cause, resolving CAPAs, and launching programs yielding capability gains and cost savings
  • Demonstrated versatility in coordinating investigations including product impact, root cause analysis, corrective actions, and effectiveness
    checks
  • Conducted comprehensive audits of live document. Championed ECN processes for manufacturing and support
  • documents and consistently executed projects within aggressive timeframes 

  CES AND SECCA, INC., Austin, Texas--2009 Company working in tandem with Texas Department of Education in procuring grants 

  Technical Writer/Document Control

  • Created Document Control Department in addition to initiating processes documents for Renewable Energy
  • Served as Educational Consultant, facilitating development of program plans for Texas schools and enabling attainment of Federal and State grants under Texas Educational Administration and No Child Left behind Act
  • Consulted about Quality Systems that needed to be considered, wrote some quality policies and procedures 

STRYKER ENDOSCOPY, Flower Mound, Texas--2008 Subsidiary of Stryker Corporation, a Global Medical Devices company

Compliance Quality Technology Consultant

  • Reviewed CAPAs with responsible Engineering to ascertain corrective action plans 
  • Ensured timely remediation of complaints and determination of MDR submissions in response to an FDA Warning Letter
  • Cut research time by 40% by assisting in the implementation of electronic system for Design History record

BAXTER HEALTHCARE, Pinellas Park, Florida--2005 Medical Devices and Services’ company   

Manager Document and Archival Control

Led 5-person team in establishing document and archival control departments yielding marked efficiency gains and reduced travel time for R & D staff by 60%

  • Supported R&D group on CAPAs and FCA activities, delivered hands-on staff training/mentoring
  • Notified Suppliers for corrective and preventative action
  • Reduced SME involvement in CAPAs 20% by volunteering to write documents for engineering
  • Responsible to ensure all equipment used for testing in test labs were calibrated and established a no access Calibration Room 
  • Cut document transfer time 50%, improved access to documents and automated retrieval process
  • Redced document backlog 30% within 4 months trough facilitating archive training
  • Achieved marked customer satisfaction gains through esigning rework/repair system reducing returns by 8%,
  •  Instituted new feedback process, installed monthly meeting with customers to obtain feedback on product use

ADDITIONAL EXPERIENCE HIGHLIGHTS:

Technical Writer/Document Control with KCI in San Antonio TX. Wrote 26 documents and collaborated with SOX Auditor ensuring compliance, corrected process documents and assisted SME on CAPAs.--2003

Quality Systems Manager with Takata in San Antonio,TX. Ensured compliance to QS 9000 and ISO 16949 for 4 Sites in Mexico.  Identified through audits document gaps and oversaw corrections.--2001
Quality Engineer with Southwest Research Institute in San Antonio. Saved $50,000 through facilitating ISO 9000 quality systems training and put in place and managed document control program.--1999                                                                                                          Quality Systems Manager with Data Race Inc., in Austin. Prepared, ensured and obtained Certification for ISO 9001. Passed subsequent 3rd party audits and retained certification --1993    

 EDUCATION AND ENHANCEMENTS

Bachelor of Science in Business Administration- University of Sindh West Pakistan

GED: Bureau of School Approvals. CA 

 

ISO 9000 Quality System Implementation and Lead Auditor Certification (SGS International Certification Services), Electronics Certificate, (Edison Technical college), Certified Auditor (American Society for Quality), Qualified Trainer, Technical Writing (Southwest Research Institute), Project Management (University of Denver),Technical Writing (University of Florida), Train the Trainer (University of Florida), Incident Investigation/Reporting, DMAIC, Critical Thinking, Problem Solving (Baxter Healthcare)



  • ID#: 69496
  • Location: Austin, TX , 78748

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