MARGARET COOK-ELLIS

**** **** **** *****

Delray Beach, FL 33484

313-***-****

adijvh@r.postjobfree.com

CAREER SUMMARY

An effective Document Control Specialist with a proven ability to manage Document Control systems, while allowing focus on continuous change and improvement. Well versed in Quality Assurance and Engineering protocol. Extensive experience in various industries; including the FAA, FDA medical devices and automotive. A meticulous professional able to resolve discrepancies and challenging situations with positive results.

RELEVANT SKILLS and KNOWLEDGE

SAP, Document Locator, Webtools, IQMS, AMICS, Solid Works, Solid Works EPDM, AutoCAD, CATIA, Microsoft Office, Word, Excel, Teams, PowerPoint, Outlook Express, Sharepoint, Adobe Acrobat, Visio, and 21CFR Part 820, cGMPs, ISO 13485 industry standards.

PROFESSIONAL EXPERIENCE

KELLY SERVICES, INC. Aug 2020 – Dec 2020

Contract to DePuy Synthes, Palm Beach Gardens, FL- Developer and manufacturer of orthopaedic and neurosurgery Medical Devices.

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Documentation Specialist

Responsible for analyzing Change Order submissions for ensuring content complied with all current policies and procedures; including involvement in implementing new change order process. Experience in a wide variety of medical device documentation.

AEROSPACE TECHNOLOGIES GROUP, Boca Raton, FL Dec 2010 – June 2020

Leading supplier and manufacturer of dual window shade systems for the commercial and corporate aviation industries

Document Control Specialist

Responsible for Document Control of engineering, quality, and manufacturing documentation

Establishing and maintaining an effective Document Control system.

Experience in Technical Writing, preparing various procedures, reports and specifications based on Subject Manner experts input.

Review of Engineering drawings for proper format of title blocks, revision control, proper approvals, and non-technical issues as they relate to the Engineering BOM’s.

Coordinated and conducted procedural internal audits; as well as participation in FAA ongoing audits to ensure company adhered to Industry requirements.

Conducted training sessions to various departments on Document Control and Quality procedures.

Management of customer data exchange portals for incoming and outgoing documentation.

Input and maintenance of Engineering Bill of Materials using AMICS and IQMS.

Ensuring proper communication, distribution, and filing of up to date documentation.

Providing reports on recently updated documents, ensuring proper distribution, and filing of electronic and paper copies.

Developing an efficient archive system of hard copy documentation.

Provided group and one on one training presentations to various departments to better facilitate understanding of Document Control’s key role and how it affects their respective departments.

Involved in Change Control Board, providing information on Engineering changes impact to various corporate components.

Responsible for release of Engineering Change Orders (ECO’s)

ADECCO TECHNICAL AND ENGINEERING, Fort Lauderdale, FL Jan. 2010 - Dec 2010

Contract to Beckman-Coulter, Inc - Developer and manufacturer of products for biomedical testing.

Documentation Specialist

Responsible for analyzing impact of engineering changes in the Product Lifecycle system, including ensuring accuracy of Bill of Materials structure.

HELLA ELECTRONICS CORPORATION, Plymouth, MI Sept. 1997- Dec. 2008

Developer and manufacturer of electro-mechanical products for the automotive industry.

Document Control Administrator

Responsible for Document Control of engineering, quality, and manufacturing documentation

Extensive experience in implementation of engineering documentation activities; including developing procedures, creating standardized templates, reviewing technical documentation in Electronic Documentation Management System for accuracy and analyzing its impact on related data.

Strong communication skills evidenced by facilitating training programs for the purpose of educating employees of Document Control procedures and proper usage of electronic document management system.

Specialized skills in creating and maintaining Document Control procedures, managing project specific records, and coordinating the archiving; and subsequent destruction; of documentation in accordance with corporate guidelines.

Excellent background in maintaining quality and technical data logs, tracking reports, and coordinating distribution of documentation to relevant personnel.

Obtained certification as an internal auditor with the intent to coordinate the engineering department registration upgrade to ISO/TS-16949.

An experienced liaison between engineering and manufacturing personnel, adept at communicating relevant changes and resolving documentation discrepancies.

Successfully managed detailed logs of engineering change requests and release of new documentation

Awarded the responsibility as point of contact to prepare for the engineering department transition to SAP-PDM, electronic document storage system.

EDUCATION

Associate Degree, Drawing and Design - Northern Michigan University, Marquette, MI

Certification, Configuration Management - Institute of Configuration Management, Scottsdale, AZ

Extension Course, Project Management Fundamentals - Walsh College, Novi, MI

SolidWorks Fundamentals, workshop - Fisher-Unitech, Troy, MI

Six Sigma Green Belt Certification, Aveta Business Institute, - Cranberry Township, PA

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