Manager Project

Kenneth Ensell

**** ******** **** . *** **** . Austin, Texas 78748

Home: 512-***-**** Mobile: 727-***-**** . abhs1v@r.postjobfree.com

Profile

TECHNICAL WRITER, QUALITY SYSTEMS

Strategic decision maker adept at supporting cross-functional teams,

driving regulatory compliance, and both developing and managing Quality

documentation, Policies and Procedures, CAPAs, Flow Charts and User Guides.

Highly skilled in troubleshooting issues, continuously improving processes,

and effectively communicating complex IT concepts. Proven track record of

excelling within demanding environments, increasing Disaster Recovery

capabilities, and garnering major efficiency gains. Fluent in English,

German, and Hindi.

Multi-Project Management . System Implementation, Management . Technical

Writing, Procedural Documentation

Analytical Problem Solving . Quality Assurance . CAPA Investigations .

Continuous Improvement . Staff Training

Business Liaison . Document Control . Internal Audits . Proofreading &

Editing . ISO, SOX & FDA Compliance

Professional Experience

ST. JUDE ADVANCED MODULATION SYSTEMS, Plano, Texas

2010

Manufacturer and distributor of cutting-edge spinal cord stimulation

system. Division of St. Jude Medical.

CAPA Project Manager

Operated as Subject Matter Expert (SME) in investigating and resolving

CAPAs, as well as launching programs yielding capability gains and cost

savings. Guided and mentored 20 lab technicians, addressing issues and

offering key insights. Demonstrated versatility in coordinating

investigations including product impact, root cause analysis, corrective

actions, and effectiveness checks. Conducted comprehensive internal audits,

championed ECN process for manufacturing and support applications, and

consistently executed projects within aggressive timeframes.

. Spearheaded CAPA investigations and drove successful resolutions,

including closing 6 CAPAs within 1 month, resulting in withdrawal of FDA

Warning Letter. Reduced SME involvement in CAPAs 20% through new

procedural documents for engineers.

. Launched and managed Supplier Chain program including audit schedules,

AVL and 1st article inspection yielding major Quality gains.

. Achieved marked customer satisfaction gains through designing

rework/repair system reducing returns 8%, as well as instituting new

feedback process.

. Garnered $75,000 in outside resource cost savings through implementing PM

and calibration program.

. Facilitated ISO compliance through guiding $150,000 project, ensuring

attainment of established milestones and driving completion 5 months

ahead of schedule.

CES AND SECCA, INC., Plano, Texas

2010

Company working in tandem with Texas Department of Education in procuring

grants for TX schools.

Technical Writer/Educational Consultant

Created high-impact marketing documentation including brochures, procedures

and process mapping for Renewable Energy and Educational Consulting

companies, addressing unique needs and providing targeted content. Served

as Educational Consultant, facilitating development of program plans for TX

schools and enabling attainment of Federal and State grants under Texas

Educational Administration and No Child Left Behind Act.

ELECTRIC RELIABILITY COUNCIL OF TEXAS, Taylor, Texas

2009

Independent agency operating electric grid and managing Texas deregulated

market.

Compliance Quality Technical Writer

Noted for high-quality technical writing, document design and layout.

Assisted in developing documentation structure and tree. Successfully

passed Federal Electrical Reliability Commission audit. Reviewed 24

documents for Critical Infrastructure Protection (CIP) NERC compliance and

implemented 10 new procedures within 10 days.

STRYKER ENDOSCOPY, Flower Mound, Texas

2008

Subsidiary of Stryker Corporation, a global medical technology company.

Responsibility for MDR fixes following FDA warning.

Compliance Quality Technology Consultant

Ensured timely remediation of complaints and determination of MDR

submission following FDA Warning Letter. Cut research time by 40% through

facilitating implementation of electronic system for Design History

records.

BAXTER HEALTHCARE, Pinellas Park, Florida

2005-2008

Medical products and services company. Responsibility for CAPA fixes

following FDA warning.

Technical Writer, Document Control/Archival Supervisor

Led 5-person team in establishing document control system yielding marked

efficiency gains, supported R&D group on CAPA and FCA activities, and

delivered hands-on staff training/mentoring.

. Developed online repository and company-first Disaster-Proof room

ensuring safety and meeting FDA requirements for 510(k) submission.

. Cut document transfer time 50%, improved access to documents and

automated retrieval process.

. Reduced document backlog 30% within 4 months through facilitating archive

training.

ADDITIONAL EXPERIENCE HIGHLIGHTS:

. Resolved quality issues and enabled successful passing of ISO and FDA

audits as Technical Writer/CAPA Specialist for Kinetic Concepts (2003-

2004).

. Drove SOX compliance through partnering with external SOX auditor and

writing 52 quality documents within 5 months. Saved $50,000 through

facilitating quality systems training necessary for ISO compliance as

Quality Systems Manager for Southwest Research Institute (2003-2004)

. Increased compliance with ISO 16945 and QS 9000 requirements across 4

offshore plants as Quality Systems Manager for Takata Seatbelts Inc.

(2001-2003).

. Enhanced compliance with ISO 9000 requirements as Quality Systems Manager

for Data Race Inc. (1999-2001).

Education & Professional Certifications

Bachelor of Science in Business Administration- University of Sindh West

Pakistan

Lead Auditor Certification (SGS International Certification Services),

Electronics Certificate, Electronic Technology (Edison Technical

Institute), Certified Auditor (American Society for Quality), Qualified

Trainer, Presentations, Technical Writing (Southwest Research Institute),

Project Management (University of Denver), ISO 9000 System Implementation

(SGS International Certification Services), Technical Writing (University

of Florida), Train the Trainer (University of Florida), Incident

Investigation/Reporting, DMAIC, Critical Thinking, Problem Solving (Baxter

Healthcare)

*Member of American Society for Quality, Society for Technical

Communication, and American Records Management Association

Kenneth Ensell

9323 Manchaca Road . Apt 1217 . Austin, Texas 78748

Home: 512-***-**** Mobile: 727-***-**** . abhs1v@r.postjobfree.com

Date: Feb 24, 2011

Dear HR Manager

As a driven and proactive professional who has supported cross-functional

teams, enhanced regulatory compliance, and both developed and managed

Quality documentation, Policies and Procedures, CAPAs, Flow Charts, and

User Guides, I am now seeking the opportunity to join a company such as

yours in a Technical Writer-Quality Systems capacity. Possessing honed

skills in troubleshooting issues, continuously improving processes, and

increasing Disaster Recovery capabilities, combined with a track record of

effectively communicating complex IT concepts, I am confident in my

abilities to excel as a member of your staff.

A sample of my highlights includes:

. Spearheading CAPA investigations and driving resolutions for St. Jude

Advanced Modulation Systems, including closing 6 CAPAs within 1 month,

resulting in withdrawal of FDA Warning Letter. Reduced SME involvement in

CAPAs 20% through new procedural documents for engineers.

. Garnering $75,000 in outside resource cost savings through implementing

PM and calibration program.

. Developing online repository and company-first Disaster-Proof room for

Baxter Healthcare ensuring safety and meeting FDA requirements for 510(k)

submission.

. Cutting document transfer time 50%, improving access to documents and

automating retrieval process.

. Saving $50,000 through facilitating quality systems training necessary

for ISO compliance at Southwest Research Institute.

Please accept this letter and enclosed resume as an introduction to my

skills and background. For a more detailed presentation of my offerings,

feel free to contact me at your earliest convenience to schedule a

conference. Thank you in advance for your consideration and I look forward

to our conversation.

Sincerely,

Kenneth Ensell

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