Documentation Control

DEBORAH KEEFE

** ****** **. • Haverhill, MA *****

*********@*****.*** • H 978-***-**** • C 978-***-****

DOCUMENTATION SPECIALIST

Highly accomplished and dedicated Documentation Specialist with proven success managing department operations, analyzing impact of product changes on manufacturing, and leading initiatives to reduce costs and cycle times. Expertise developing Documentation department from ground up with no supervision needed. Minor changes on all in house drawings using SolidWorks. Design all in-house artwork, developing standard operating procedures, and managing bill of materials, parts, and engineering change orders. Strong leadership abilities in training, supervising, and evaluating up to 5 employees. Excellent interpersonal abilities with all levels of staff, vendors, and upper executives. Track record for contributions to company growth and profitability.

Core Competencies:

• Drawing redline Changes• Staff Training & Supervision• Executive Presentations • EngineeringChange Orders• Adobe Illustrator• Agile • Photoshop• ISO Procedures• Problem Solving

PROFESSIONAL EXPERIENCE

GE HEALTHCARE - Lawrence, MA 2009 to Present

Diversified company with Healthcare being a $15 billion unit of General Electric Company

Documentation Specialist (Contract)

Control all in house documentation from Engineering standards, SOP’s, Regulatory files. Cheer weekly Change Control Board meeting. Support the whole organization with ECO creation and control. Provide input in regards to FDA regulations. Update all MS Project documents. Work closely with other individuals to create and update user manuals and service manuals. Update and create all in house label artwork using Adobe Illustrator.

Key Achievements:

· Incorporated new processes to help streamline the business.

· Organized and chair weekly Change Control Board (CCB) meeting.

· Incorporated better tracking ability for all revised and newly created documents.

PHILIPS HEALTHCARE - ANDOVER. MA 2007 to 2009

Diversified Health and Well-being company, focused on improving people’s lives through

timely innovations.

Sr. Documentation Specialist

Created all change notices for new and existing product lines. Co-cheered weekly change notice meeting for timely implementation of changes. Participated in planning of engineering change notices for implementation into Manufacturing. Trained all personnel on Matrix system. Took on role of acting Product Change Coordinator, which controlled all CN activity and scrap costs. Responsible for the creation and edits to all in house labels using Adobe Illustrator.

Key Achievements:

· Cheered weekly Change Notice (CN) Meeting.

· Trained all employees on the Matrix System.

· Responsible for all routes and CN creation and edits via the Matrix System.

· Alleviated the Engineers of unnecessary work to enhance their expertise.

· Created and maintained all in house label artwork using Adobe Illustrator.

· Updated Mechanical drawings using Co-Create and Pro Engineer.

· Tracked all system failures and fixes.

Thermal Fisher Scientific - Beverly, MA 2007 to 2007

7 Month Contract Position

Lead Documentation Specialist

Developed documentation department from ground up with no supervision. Incorporated a locked documentation room for all drawings, ECO’s, SOP’s and any other confidential documentation. Assisted all Engineers with drawing requests and creation of ECO’s. Held weekly CCB meeting with various departments for sign off on proposed changes. Responsible for contents of all ECO’s and drawings in regards to drawing changes, word changes, label changes etc, from start to finish. Responsible for all signatures on ECO’s and material impact of changes. Worked closely with the materials department for any scrap and rework costs. Worked independently with FDA when visiting the facility for routine audits.

Key Achievements

· Cheered weekly CCB Meeting.

· Responsible for all signatures on ECO’s.

· Alleviated the Engineers of unnecessary work to enhance their expertise.

· Created and maintained all in house label artwork using Adobe Illustrator.

· Updated Mechanical drawings using AutoCad.

GE HEALTHCARE - Lawrence, MA 2006 to 2007

Diversified company with Healthcare being a $15 billion unit of General Electric Company

Lead Documentation Specialist

Controlled all in house documentation from Engineering standards, SOP’s, Regulatory files and all controlled documents in a locked secured area. Trained all personnel on new controlled area procedure. Took on role of acting Engineering Manager, which controlled the Engineering department as well as day-to-day business activities. Communicate with marketing on all new logos and graphics. Train new hires and existing employees.

Key Achievements:

· Planned and implemented a Product Data Management System (PDM).

· Trained all employees on the PDM system.

· Incorporated new processes to help streamline the business.

· Incorporated all redline drawing changes using SolidWorks.

· Incorporated better tracking ability for all revised and newly created documents.

· Organized and chair weekly Change Control Board (CCB) meeting.

· Implemented Recycling Program.

ZOLL MEDICAL CORPORATION - Chelmsford, MA 1999 to 2006

Established company specializing in medical resuscitation with $18 to $20 million in annual revenues.

Documentation Supervisor

Managed documentation department including staffing, print production, and cost control. Communicate with marketing on all new logos and graphics. Oversee production of all in house artwork design concepts. Work closely with outside printers for accurate pantone coloring and artwork placement. Train new hires and existing employees. Facilitate annual performance evaluations. Track and report to VP of Operations on department expenses and ROI.

Key Achievements:

· Planned and implemented an in-house Copy Express Center which eliminated outsourcing costs.

· Streamlined the engineering change order (ECO) process to reduce cycle times.

· Instrumental in suggesting conversion to product lifecycle management (PLM) system.

· Researched new label design to simplify process for in-house artwork.

· Train and coach all personnel on development of new graphic and artwork designs.

· Serve as active member of the Oracle implementation team.

EATON CORPORATION - Beverly, MA 1995 to 1999

Global leader in electrical systems and components with $11.5 billion in annual revenues.

ECO Planner (1997 to 1999)

Participated in planning of engineering change orders for implementation into manufacturing. Reviewed and analyzed engineering changes for impact on the master production schedule, inventory levels, production processes, and unit/machine costs. Prepared implementation plans for product changes. Monitored open purchase orders. Tracked field service requirements.

Key Achievements:

· Instrumental in reducing manufacturing costs by streamlining ECO approval process.

· Implemented a waste management program by managing monthly scrap materials.

· Worked closely with manufacturing groups to ensure implementation of product changes.

Sr. Documentation Specialist (1994 to 1997)

Managed all document control systems, engineering change orders, and bills of materials. Led bi-weekly staff meetings to discuss goals and directives. Trained new and existing personnel on department procedures. Processed and tracked all purchase orders for parts. Coordinated a weekly board meeting on change control. Assisted project managers with special projects.

Key Achievements:

· Provided key leadership for implementation of a PDM system which dramatically reduced costs and time to market.

· Worked closely with management teams to analyze impact of all engineering changes.

· Maintained compliance with ISO requirements for all internal/external audits.

* * * * *

Additional experience

Served as Senior Documentation Specialist, ZOLL Medical Corporation.

Served as Documentation Coordinator/Desktop Publications, Eaton Corporation.

Served as Documentation Specialist, Analogic Corporation.

CERTIFICATIONS

Frame Maker • Engineering Documentation Control • QuarkXpress

Desktop Design • WordPerfect • MS Word

Contact this candidate