Quality Assurance Risk Management

Marcia M. Weeden

** ***** *****, **********, ** *2806

401-***-**** – landline

*****************@***.***

Regulatory compliance, global standards & harmonization, MDR 2017-745, FDA, risk management, quality management system (QMS,) compliance analysis, gap analysis, auditing, complaints, root cause analysis, presentations, training, & technical writing

Member – American Society for Quality (ASQ) and American Association of Textile Chemists & Colorists (AATCC)

Myers-Briggs Personality – ENTP (The Inventor)

Medical device & pharmaceutical contract and permanent positions below

Technical Writer Quality Engineer, Pfizer, Groton, CT – 3/5/23 to 12/22/23

Converted documents into new format and aligned with NIST requirements for Pharmaceutical Sciences Small Molecule (PSSM) pilot plant’s CMC calibration program including

GDMS (Global Document Management System,) and

EAMS (Enterprise Asset Management System)

Quality Manager, Regulatory & Compliance Specialist, Aidance Scientific, Inc., Woonsocket, RI – 1/5/22 to 1/20/23

Quality Risk Management Program (QRMS) program

Achieved compliance for California Pharmaceutical and Drugs take-back program

Aidance rep – FDA, Pharmaceutical Product Stewardship Work Group (PPSWG) & PPSWG’s CIRP (Communications, Industry Relations, and Policy) Committee

Post-market surveillance program

SOPs, Work Instructions, forms for CMC and QMS compliance and dossier submissions

PowerPoint lessons – quality costs, regulatory requirements, Malcolm Baldrige & quality tools

Senior Regulatory Compliance Engineer, Huestis Medical, Bristol, RI – 10/21/19 to 12/30/21

Created

Quality Risk Management Program (QRMP) – MDR 2017-745

SOPs & WIs, project plans, IQ/OQ/PQ, design development, supplier management program

SOPs and other technical documentation for MDR 2017-745, IEC 60601-X series, IEC 62304, IEC 62366 for EU submissions

Risk assessment & project plans, risk assessments, product development, design controls, CAPAs

Synopsis sheets for MDR-2017-745, Harmonized Standards & Collateral Standards, IEC 60601 Collateral & Particular Standards, EU Ruling Classifications, MDSAP

Document Control SOP & WI

PowerPoints on The 5 Industrial Revolutions and Evolution of Quality and Regulatory Standards & The Evolution and Future of Medical Device Standards

Post-market surveillance

Document Control Specialist, Instrumentation Laboratory, Bedford, MA – 6/17/19 to 10/18/19

Coordinated medical device IFUs & other labeling products for medical devices for translated offshore languages to English including translation certifications

Gap analysis and verification of English versions of offshore IFUs

Gap analysis of multiple translation procedures for regulatory compliance

Harmonized documents between Bedford, MA and Orangeburg, NY sites

Quality Engineer, DePuy Synthes, Johnson & Johnson, Raynham, MA – 1/28/19 to 3/7/19

Created instructor training information documents for CAPA and CAPA Review Board SOPs

Quality Consultant/Technical Writer, Boston Consulting Group – 11/30/18 – 12/31/18

Developed work instructions for BCG’s client’s medical device

Reviewed developed document for compliance with and gaps regarding ISO 13485 & FDA 21 CFR 820

Provided guidance for compliance with ISO 13485 & FDA 21 CFR 820

Quality Consultant/Technical Writer, Diversified – Medical Innovation Group, Dallas, Texas – 11/27/17 – 2/9/18

Provided expertise for quality strategy

Developed white paper on background information for new product for use in integrated operating rooms

Developed white paper on MDSAP (Medical Device Single Audit Program)

Developed white paper on FDA Requirements

Technical Writer & Quality Consultant, Pfizer, Inc., Drug Product Design (DPD) division, Groton, CT – 4/3/17 to 12/11/17

Developed white paper for second phase of a new manufacturing process (part-time remote work)

Regulatory Affairs Technical Writer, DePuy Mitek, Johnson & Johnson, Raynham, MA – 2/16/16 to 7/6/17

Updated and improved IFUs (Information for Use) for medical devices

Created template for medical device maintenance and troubleshooting manuals

Revised medical device maintenance and troubleshooting manuals

Documented technical writing procedures relevant to Regulatory Affairs

Technical Writer & Quality Consultant, Pfizer, Inc., Drug Product Design (DPD) division, Groton, CT – 10/20/14 to 7/31/15

QA assessment & SOP recommendations for CMC regulatory compliance & improvements

Developed, reviewed, & revised white papers, sections of regulatory submissions, and publications

Tech writing for Pfizerpedia – website improvements – harmonized information for uniform presentation

Communications Team – articles, interviews, Team manual

Proofread regulatory submission documents – verified data

Gap analyses of QA SOPs against FDA requirements, 21 CFR 820.30, Design Controls

Data verification

Quality Engineer/Developer/Technical Writer, Accellent, Inc., Brimfield, MA – 04/5/10 to 10/29/10

Orthopaedic medical devices & instruments

Team member for FDA audit readiness and compliance

Wrote IQ/OQ/PQ validations for compliance with DePuy medical device requirements

Created safety manuals, preventive maintenance and troubleshooting manuals, SOPs/work instructions, and forms

Developed & taught training PowerPoint for ultrasonic cleaning

Supplier Quality Engineer, DePuy Orthopedics, Johnson & Johnson, Raynham, MA – 4/7/08 to 12/31/08

Supplier quality engineering for orthopedic medical devices

Reviewed supplier documentation for CHC regulatory compliance

Document management of process verification activities in Agile

Development of product inspection criteria (PIC) for incoming inspection worksheets

QA Consultant & Developer/Technical Writer, DePuy Spine, Inc., Johnson & Johnson, Raynham, MA – 7/6/04 to 7/29/05

Gap analyses & CAPA of Design Engineering for improvement opportunities – recommendations implemented

Conducted PME Project (People, Methods, Measurements, Machines, Materials, Methods, & Environment) including interviewing, analysis, and summaries of statements.

Recommended that Engineering Services change its name to "Design Engineering" based upon above study and results. This and other recommendations accepted

Gap analyses & CAPA for case-and-tray development process with outside supplier manufacturer – developed cross-department function SOP

Created process flowcharts documenting Design Engineering’s workflows

Developed Work Instructions (SOP) and flowcharted multi-department Case-and-Tray Development Process

Developed & revised SOPs & Work Instructions

Engineering Technology Team

Developer/Technical Writer, Information Mapping, Waltham, MA – 7/1/00-6/29/01

Developed integrated SOPs in response to a decree sanction for pharmaceutical manufacturer, Wyeth-Lederle

Recommended revising approaches to develop integrated CMC SOPs to ensure quality and for regulatory compliance in manufacturing environment, approved by pharmaceutical manufacturer, and adopted for all project developers

Received training in Information Mapping method and hand-groomed by Information Mapping editors in method

Non-Medical Contract Positions

Supplier Quality Engineer, Crestron Electronics, Orangeburg, NY – 7/10/17 to 11/17/17

Responsible for Material Approval Program (MAP) for new supplier contracts and engineering work orders including revising procedures, forms, and transferring information requirements to purchasing phase

Developed L*a*b* shade matching program

Developed calibration and process control program for suppliers

Developed CAPA instructions for offshore manufacturers

Technical Writer, Coorstek, Golden, CO – 2/29/16 – 6/3/16

Worked with IT development team to create WIs (work instructions) for new QMS reporting system

Developed WI template for QMS reporting system

Developed WIs for various elements of the QMS reporting system, e.g., create new document, drawing, NCR, skill, inactivate an employee, revise documents, create record, submit a change request etc.

Quality Consultant – US Navy Textile and Clothing Research Facility, Natick, MA – 10/2002-3/2003

Analyzed quality assurance issues & created appropriate solutions

Developed and revised technical documents

Developed and taught courses related to quality assurance & calibration

Legal Secretary – Rego & Rego – 8/05 to 3/06; 6/07 to 1/08; 3/08 to 4/08

Wills, probate, collections, bankruptcies, real estate, closings, zoning, incorporations, correspondence, appointments, & scheduling

Non-Medical Permanent Positions

Quality & Standards Senior Analyst in Service Excellence and Program Compliance department for Dell, Inc., on Blue Cross/Blue Shield of RI client, Providence, RI – fulltime, permanent position – 4 /11 to 8/13

Improved operational efficiency Dell's Providence in-house processes via harmonizing BCBSRI's & corporate Dell's policies and requirements

Established SOP format & document control system

Senior HIPAA investigator – spearheaded root cause analyses and CAPAs for HIPAA violations

Wrote “The Truth about Six Sigma,” focusing on accurate and inaccurate applications of Six Sigma

Developed five (5) Purchasing SOPs deemed "best practices" by corporate Dell purchasing group

Quality Process Engineer, Joan Fabrics Corporation, Inc., Fall River, MA (Main Street Textiles division) – 1/95 to 2/96

QS 9000 coordinator for Fall River – company rep for automotive and upholstery auditors

Responsible for PPAPs and FMEAs for automotive upholstery – company representative for third-party quality and compliance inspections

Developed, wrote, and implemented systems for ISO 9001 and upholstered office furniture industry

7/92 to 12/94 – Bad pregnancy, cancer, & father terminally ill

Director of Quality Assurance & Consumer Safety, Eden Toys, Jersey City, NJ – 12/89 to 6/92

Managed $750,000 department budget

Toy Manufacturers of America (TMA) rep on CPSC (Consumer Product Safety Commission) committees for harmonizing US crib toys, pacifiers, & plastic bags safety requirements with worldwide safety requirements

TMA committee member for revising ASTM F963, US Toy Safety standard

Ensured Design & Engineering met toy safety requirements for consumer use

Ensured compliance with ASTM F-963 & worldwide toy safety requirements

Managed quality issues re: new product development, manufacturing, complaints

Handled all consumer complaints & related CAPAs – liaised with TMA attorney & Eden Toys CEO on sensitive complaint issues

Tasked by CEO to determine failure of offshore quality inspection manual – conducted CAPA – revised manual using statistical sampling for part & product testing, assembly validations, & visual inspections – praised by Eden Toys’ European distributor which adopted manual for its use

Developed system for transferring aesthetic standards and requirements to offshore manufacturers and Eden’s inspection teams

Performed onsite qualifications of offshore manufacturers & potential suppliers

Directed overseas QA and in-house quality inspection and testing teams

Managed Eden’s overseas inspection teams for China, Haiti, Hong Kong, Korea, the Philippines, Taiwan, and Thailand manufacturers

Collaborated with Engineering to evaluate potential suppliers for manufacturing suitability

Collaborated with Design development team on concepts & design development

Approved suppliers’ parts assembly, manufacturing methods, testing, and validation for safety & assembly

Proofed all bills of materials & work instructions prior to transferring to offshore manufacturers

Director of Quality Assurance, Duro Industries, Fall River, MA – 7/86 to 11/89

Compliance for Defense quality, safety, and inspection

Frequent interfacing with DOD agencies & contractors

Participant with W.L. Gore, US Army Natick, & DPSC color matching lab to develop L*a*b* standards

Addressed quality issues regarding new product development, manufacturing, & complaints

Directed QA at three manufacturing plants – oversaw all CAPAs and CMC procedures and testing

Developed $25.00 alternative to a 3-year bonded warehouse Defense requirement – adopted by US Army

Initiated & spearheaded CAPA investigation that overturned a $7 million Defense rejection

Numerous recommendations to improve DOD textile specifications and test methods that were accepted by the US Army

Oversaw three in-house testing laboratories – achieved qualify inclusion on Defense Personnel Supply Center's Qualified Laboratory List (QLL)

Established Mil-Std-45662 calibration program

Developed & implemented document control system

Created & taught textile technician training program for Defense textile specifications & test methods

Quality Assurance Representative (QAR), Defense Contract Administrative Services (DCAS,) Boston – 8/83 to 7/86

Top Secret clearance – (currently inactive)

DOD certified in Clothing and Textiles

Ensured DOD’s quality & testing requirements were carried out at contractors

Extensive training in contractor fraud

Selected for pilot L*a*b* color-matching training

DOD certified in clothing and textiles

Performed First Article inspections

Education & Professional Development

MS, Textiles, Clothing, & Related Art with specializations in Quality Assurance and Adult Education, University of Rhode Island

BA, History, University of Rhode Island (URI) – Emphasis on social and cultural history

Certificate, The Art of Creativity – Rhode Island School of Design – Completed March 2024

Certificate, Quality Control Management & Engineering, URI Extension & RI American Society for Quality (ASQ)

Certified Quality Engineer (ASQ CQE #15066) – American Society for Quality – 18 years

Certified Quality Technician (ASQ CQT #T1557) – American Society for Quality – lifetime

Publications

American Society for Quality (ASQ) – Quality Progress – ASQ’s monthly flagship publication that reaches 77,000+ quality professionals and practitioners worldwide – peer reviewed – Quality Press – ASQ’s book publishing division

Books

Failure Mode and Effects Analysis (FMEAs) for Small Business Owners and Non-Engineers: Determining and Preventing What Can Go Wrong – Quality Press, division of American Society for Quality (ASQ) – November 2015 – book offered by ASQ as a July 2023 77,000+ member benefit

Stalking the Stalking: A Guidance Manual for Stalking Targets and Their Advocates – in development

Articles – Published by the ASQ’s Quality Progress

“Documentation Structure for Regulatory Compliance” – Article to be published in December 2024 issue

“Pyramid Scheme – A framework for stronger operating procedures” – January 2016 issue – Selected as one of the 50 best back-to-basics articles from 2001 to 2015 for “Documentation” category

“Who believes in this nonsense” (original title: Six Sigma – Walking the walk or talking the talk) – May 2015 issue – ASQ’s Six Sigma Forum Magazine

“US Secretary of Quality – Optimizing government, infusing quality at the executive level” – December 2014 issue

“Full Circle – Systematically review and revise your standard operating procedures” – November 2014 issue

“Pyramid Scheme – A framework for stronger operating procedures” – December 2013 issue

“Show & Tell – How do quality professionals explain their jobs” – March 2013 issue

Speaker Presentations – American Society for Quality

ASQ Reliability & Risk Division, Reliability, Maintenance & Managing Risk Conference, Hartford, CT – August 2-3, 2022, Presented Quality, Risk, & FMEAs

Portland / Vancouver ASQ Section – April 12, 2022, speaker – MDR 2017 – Honeycomb of Standards

Rhode Island ASQ Section – May 22, 2014, dinner speaker – The Quality of Color

Thames Valley (CT) ASQ Section – June 2013 dinner meeting speaker – Quality Professionals – Who We Are, How We Got Here, Where We’re Going

Olde Colony (MA) ASQ Section – October 2012 dinner meeting speaker – QA for Color

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