MARCIA M. WEEDEN
25 Joann Drive
Barrington, RI  02806
 [Send email to request phone number] 46-3204 – home
[Send email using form at bottom]

 
SUMMARY & ACCOMPLISHMENTS
 
Creative & innovative quality assurance professional highly experienced with
analysis and management of systems to achieve goals, regulatory compliance, and
reduce costs.  Trained technical writer.  Implementing and coordinating quality
assurance & regulatory compliance efforts related to
 
• business analysis & risk assessments
• process flows, evaluations, & system improvements 
• configuration management 
• document control, data capturing, & technical writing 
• product safety & regulatory compliance 
• verification and validation
• auditing & gap analyses
• root cause analysis & corrective & preventive action 
• supply chain analysis, and 
• training. 
 
Master’s of Science in Textiles, Clothing, & Related Art (MS) – Specializing in
quality assurance & adult education/training – University of Rhode Island

ASQ Certified Quality Engineer & ASQ Certified Quality Technician 

Green Belt and Black Belt Six Sigma Certificate Programs – Bryant University –
Courses began September 1, 2009

Myers-Briggs Personality – The Inventor
 
• Initiated investigation that spared textile and garment contractors from a $7
million Defense rejection.  
• Analyzed Design Services Department at DePuy Spine.  Recommended changing
department name to Design Engineering, which was accepted. 
• Devised $25.00 solution that eliminated 3-year bonded warehouse Defense
contract requirement, which was recommended for adoption by US Army.  
 	
COMPUTER SKILLS

Microsoft Office Suite 2007, Word, Excel, PowerPoint, Visio, Access, Agile,
Information Mapping, Acrobat Reader & Writer, Lotus Notes, PrintShop, FrameMaker,
Internet, Outlook Express, & desktop publishing.  60 wpm.
 

EXPERIENCE
 
QUALITY CONSULTANT/TECH WRITER 
Self-employed as Quality Excellence Services (QES), Barrington, RI – 12/96 to
present
Quality assurance, TQM, SPC, & SQC.  ISO 9001, ISO 13485, cGMP, DOD, & HIPAA. 
Analysis & improvement of corporate quality systems including identifying and
monitoring metrics.  Regulatory compliance & audits. Gap analyses.  Verification
& validation.  Internal audits & audit training.  Strong cross-functional team
experience.  Statistical analyses.  Technical writing.  Vendor & customer
relations.  Needs assessments.  Customized quality assurance & regulatory
compliance training programs.  Corporate quality awareness.  Customer
satisfaction.  Product development.  Design review.  Continuous improvement &
root cause analysis.  Corrective & preventive action.  Quality costs.  
 
SELECTED QES PROJECTS & CLIENTS
 
SUPPLIER QUALITY ENGINEER
DePuy Orthopaedics, Johnson & Johnson, Raynham, MA – 4/08 to 12/31/08
Supplier quality engineering for orthopaedic medical devices.  Document
management of process verification activities for Agile.  Development of product
inspection criteria (PIC) incoming inspection worksheets.

QUALITY CONSULTANT/DEVELOPER/TECH WRITER
DePuy Spine, Johnson & Johnson, Raynham, MA – 7/04 to 7/05
Spine medical devices.  Conducted project to determine department’s activities,
strengths, & challenges.  Developed Work Instructions (SOPs) for Design Engineers
for Agile.  Changed name of department to Design Engineering.  Member of R&D
technology team.  

QUALITY CONSULTANT/TECH WRITER
US Navy Clothing & Textiles Research Facility (NCTRF), Natick, MA – 10/02 to
3/03
Analyzed quality issues & created appropriate solutions.  Developed Shade SOP. 
Developed & taught class on Ishikawa Diagrams, a.k.a. Fish Diagrams:  A Quality
Assurance Tool for Root Cause Analysis.  

DEVELOPER/TECH WRITER
Information Mapping, Inc., Waltham, MA – 8/00 to 6/01
Wrote pharmaceutical SOPs, integrated batch records, & batch records for major
pharmaceutical manufacturer, Wyeth-Lederle including signature requirements. 
Verification.  Received certificate in Information Mapping, Inc.’s Developing
Procedures, Policies, & Documentation.  Used The Chicago Manual for Style.

QUALITY CONSULTANT/DEVELOPER/TECH WRITER
Roma Color, Inc., Fall River, MA (Organic Pigment Manufacturing) – 3/97 to 3/99
Developed, wrote, & taught course material related to quality assurance & ISO
9001 procedures.  Developed & implemented programs for corporate quality
awareness, root cause analysis, quality costs, & calibration.  Document control. 
Data capturing & quality records.  


EMPLOYERS

QUALITY PROCESS ENGINEER – 1/95 to 2/96
Joan Fabrics Corporation, Inc., Fall River, MA (Main Street Textiles division) –

QS 9000 coordinator for Fall River.  Tech writer.  Wrote PPAPs & FMEAs for
automotive upholstery.  Created, wrote, & implemented systems for ISO 9001 & the
upholstered office furniture industry.  Supply chain analysis.  Document control.
 Formalized production trial procedures.

DIRECTOR OF QUALITY ASSURANCE & CONSUMER SAFETY – 12/89 to 6/92
Eden Toys, Inc., Jersey City, NJ – 
Managed $750,000 department budget.  Ensured compliance with worldwide,
toy-safety & packaging requirements, & CE marking via risk assessments.  Ensured
quality & safety requirements were transferred to offshore manufacturers &
inspection teams.  Handled all consumer complaints.  Member of TMA (Toy
Manufacturers of America) & CPSC (Consumer Product Safety Commission) technical
review committees on revising ASTM F963 toy safety standards, crib toy safety, &
harmonizing worldwide toy safety requirements.  Worked directly with overseas
manufacturers to resolve quality issues.  Developed, wrote, & implemented
overseas & in-house quality assurance programs.  Trained overseas inspectors, QA
managers, & manufacturing partners in quality & toy safety standards.  TQM.   

DIRECTOR OF QUALITY ASSURANCE – 7/86 to 11/89
Duro Industries, Inc., Fall River, MA – 
Ensured company’s compliance with Defense & Postal contracts for three plants.
Frequent interfacing with Government buying activities, U.S. Army Natick Research
& Development Center, & DOD prime contractors.  Oversaw three QA laboratories;
achieved & ensured compliance with DOD Qualified Laboratory List (QLL)
requirements.  Created & taught first US QC-technician training program for
textile military specifications & test methods.  Ensured compliance with
Mil-I-45208A (DOD inspection requirements,) Mil-Std-45662A (calibration,) & DOD
Manufacturing Process Controls & In-Process Inspections.  
 
QUALITY ASSURANCE REPRESENTATIVE (DCAS QAR) – 8/83 to 7/86
Defense Contract Administration Services, Boston (DCAS) – 
Ensured DOD’s quality requirements were carried out at Defense contractors
through auditing & inspections.  Top Secret clearance.  Configuration management.
 DOD certified in blueprint reading.  Performed First Article inspections. 
Extensive training & experience with Mil-Q-9858A (DOD quality system
requirements,) Mil-I-45208A, & Mil-Std-45662A & various manufacturing, packaging,
& shipping requirements.  Certified Quality Circle facilitator.  Certified in
“Training the Trainer.”
 
INTERNATIONAL
 
• Extensive QA business travel to Pacific Rim & Haitian manufacturers & QA
inspection teams.  
• Lived in Norway for four years.  Fluent Norwegian.  Good understanding of
Swedish. 
• Numerous technical committees’ member involved with harmonizing international,
toy-safety requirements or textile testing methods.

 ADVOCACY EXPERIENCE
 
RHODE ISLAND CHAPTER DIRECTOR – 10/04 to present
Parents Television Council (PTC,) Los Angeles, CA, www.parentstv.org 
Advocate for media impact on children.  Authored multiple Op Ed pieces
pertaining to the PTC, including one picked up by the newswires and published
nationwide.  Recognized Op Ed contributor to The Providence Journal.  Interviewed
on television by Frank Coletta on WJAR’s live news at 5:30 on May 1, 2008
regarding the adverse impact of the video game, Grand Theft Auto 4.  Contact with
RI Senators’ and Congressman Patrick Kennedy’s offices on behalf of the PTC. 
Seeking passage of RI bill to restrict sale of violent videos games intended for
adults to minors.