Management System Quality
Resume:
Theodora G. Jones
Kenosha, WI *****
*************@**.**.***
Professional Summary:
Over twenty five years’ experience in Total Quality Management (TQM) specializing in Quality Management System (QMS)/Quality Systems Regulation (QSR); with a primary focus on harmonization of Device Master/History Records (DMR & DHF), and implementation of processes, assessments and execution of Corrective & Preventive Actions (CAPA) Plans, Complaint Nonconformance Management: ISO 9001, ISO 13485:2003, ISO 14971, MDR 2017/745-746, 21 CFR 820, 803, 806, CFR Part 11, European & Canadian Medical Device Regulations SOR 98-282, European MDD harmonized standards 93/42/EEC, and OSHA for Class I and II Medical Devices. Since leaving the military, my primary assignments have been as a contract/consultant with OEM’s experiencing some form of remediation and/or FDA warning.
Business Project Management, Change Management Control (CMC (ECO &ECN’s), GAP Analyses, Continuous Improvement and Statistical performance applied for Corrective and Preventive Action (CAPA), Complaint Handling, Return Material Authorization (RMA), Document Control, Supplier Management, Remediation, Society Human Resource Management (SHRM), Learning Management System (LMS) Employee Training, Regulatory Affairs, and Hazard (EHS) Communications for multiple sites.
Possess advanced/expert experience with Microsoft Office Suites (MSWord, Excel, PowerPoint, MS Project), Access, Oracle, CATSWeb, EtQ, Agile, TrackWise, SAP, Learning Management System (LMS), E-Synergy, JD Edwards, AS 400 and SharePoint
Medical devices include; spinal and orthopedic surgical instruments/implants, pharmaceuticals, combination products/auto injectors, defibrillators, printed circuit boards (Logic & Power Supply), monitoring and imaging equipment, various pumps, nebulizers, blood pressure monitors and thermometry.
Quality system projects: Program Manager of printed circuit boards (PCB) and electronic systems, development of Document Management (Change Control (ECN) & SOP), audit programs, Learning Management System (LMS) employee training and development, Kaizen method, failure evaluations/investigations, Remediation, CAPA Management, complaint/MDR analyses (adverse events), design controls; PFMEAs, FMEAs development and quality control plans, determinations and potential risk (ISO 14971) reviews, Return Material Authorization (RMA), Product Recalls, supplier management evaluation & controls and GTIN (UDI).
Education and Skills:
Bachelor of Science in Business
Electricians Mate (Basic & Advanced Training)
(EHS) Hazardous Material/Handler & Safety Coordinator, HAZWOPER
Professional experiences:
Prokatchers/Abbott Laboratories-Waukegan, IL Aug 2023-Oct 2024
Sr. Quality Engineer
• BTS IT CAPA Management Team
• Abbott Certified CAPA Event Owner, Resolution Planner, Implementer & Investigator
• Excellent analytical, judgment, and consultative capabilities.
• The ability to work with both IT management and staff.
• Builds needed relationships and drives for results.
• Excellent written communication skills.
eTeam – Round Lake, IL Sep 2022 – Dec 2022
CAPA Engineer
Perform non-conformance (Client) investigations within the Track Wise 8 Management System.
Execute implementation of CAPAs associated with Client investigations.
Enhanced Compliance INC – Stevensville, MI Mar 2022 – July 2022
Sr. Post Market Surveillance Consultant
Perform product recall related activities in compliance of applicable regulatory requirements (21CFR 806 and Part 7), planning, execution, customer letters, field actions, product returns, reporting and closure activities
Support management of nonconforming product quarantines, product holds and field corrective actions.
Initiate Product impact Statements Health Hazard Analysis and Risk Assessments
Change Management Control (CMC (ECO &ECN’s)
Develop or support FCA regulatory reporting practices for US and Internationally
Provide technical support for the improvement of policies and standard operating procedures (SOP) associated with Field Action/Recall
Discovery Solutions - Lewes, DE Feb 2021 – Feb 2022
Medical Complaints Consultant
Support the client’s complaints investigation closure project for backlog complaints, issues, etc. that have come in from end users regarding Class I and II devices (e.g. combination products/auto injectors).
Aerotek - Schaumburg, IL Sep 2018 - Apr 2019
Catalent Pharmaceutical CAPA Consultant/Technical Writer – Woodstock, IL
Interfaces with Manufacturing, Quality Assurance, Continuous Improvement and other functional areas to ensure thorough investigation of root cause; identify and formulate CAPA strategies.
Change Management Control (CMC (ECO &ECN’s)
Performs thorough investigations of manufacturing nonconforming events that could include review of cGMP docs: (Batch records, maintenance work orders, engineering protocols, lab results, and historical review of Quality Management System).
Zimmer Biomet - Warsaw, IN Feb 2017 - Apr 2018
Consultant, Medical devices, Post Market Surveillance Specialist
Trauma, Spine, Knees, Hips, CMF, Biomaterials complaint investigations and closings
Return Material Authorization (RMA)
Provides product and process technical training PFMEAs, FMEAs development and quality control plans, determinations and potential risk (ISO 14971) reviews to salaried and hourly staff members.
Update existing or create new procedures to embed UDI compliance; add GTIN (UDI) to eMDR process.
GE Healthcare - Milwaukee, WI Jun 2016 - Oct 2016
Technical Writer
Auditor of existing quality record documentation (Life Cycle System and Lunar) for transfer of manufacturing.
Execute documentation obsolescence activities: modifications, approvals, archival.
Establish and harmonize processes for referencing of documentation for other manufacturing sites.
Midmark - Lincolnshire, IL Aug 2015 - Feb 2016
Post Market Surveillance Specialist
Responsible for maintenance, closing, tracking and trending of product complaints and nonconformance reports (NCRs) for leading Dental Imaging (X-Ray) equipment; preparation for Complaint Management transition to Agile database 2016.
Accuray - Madison, WI Apr 2015 - Jul 2015
Product Complaint Specialist
Responsible for maintenance, closing, tracking and trending of product complaints and nonconformance reports (NCRs) for leading manufacturer of cancer treatment and detection (Radiation Therapy/Diagnostics-Tomotherapy and Cyberknife) equipment.
Return Material Authorization (RMA)
Johnson & Johnson DePuy Synthes - West Chester, PA Apr 2014 - Oct 2014
Sr. Compliance and Quality Consultant - MDR
MDR Specialist responsible integration and harmonization for (FDA) Mandatory Reporting requirements MEDWATCH 3500A for leading manufacturer of Trauma, Spine, CMF, Biomaterials, Power Tools and Veterinary medical device instruments and implants.
Change Management Control (CMC (ECO &ECN’s),
Update existing or create new procedures to embed UDI compliance; add GTIN (UDI) to eMDR process.
Bradshaw Medical Inc - Kenosha, WI Dec 2012 – Jan 2014
Regulatory Affairs Specialist
Responsible for formulation, integration, initiation, maintenance, closing, tracking, trending, of Corrective & Preventive Actions (CAPA) Plans.
Update existing or create new procedures to embed UDI compliance; add GTIN (UDI) to eMDR process.
Complaints and Nonconformance (NCR) Management and standard operating procedures (SOP)
Return Material Authorization (RMA)
Medela - McHenry - IL Nov 2012 – Dec 2012
Quality Assurance Complaint Specialist
Worked with most successful breast pump manufacturer in Complaint Handling Unit (CHU) auditing for closure (30,000) complaints and nonconformance reports (NCRs) for system software upgrades scheduled 2013
Briggs Healthcare - Waukegan, IL Nov 2008 – May 2012
Quality Assurance Documentation Specialist
Responsible for implementation and harmonization of Change Management Control (CMC, ECO &ECN’s), Document Change/Control Management Systems; ensuring SOP(s) and regulatory documentation compliance with 21 CFR 820 & ISO 13485 requirements.
Input and maintenance of databases for Complaints and nonconformance reports (NCRs), MDR Sheets, SCAR(s), MEDWATCH, CAPA(s), Document Change Control, Training and Internal Audits
Dallas & Mavis Specialized Carriers - Kenosha, WI Nov 2004 – Jun 2006
Safety Compliance Auditor
Primary responsibilities included documentation, notification, tracking and reporting to Executive Management occurrences of Roadside Inspections and the outcome. Review of driver qualifications, references and scheduling drug screenings for Federal Motor Carrier Compliance.
Sanmina SCI Corporation - Kenosha, WI Aug 1999 – Mar 2004
Program Manager
Liaison Product/Program manager for clients (Motorola, GE Transportation, StorageTek and Rockwell First Point Contact) ensuring Total Customer Satisfaction through the receipt, acknowledgement, review, submission, and planning of new product design consignment inventories, Change Management Control (CMC (ECO &ECN’s), complaints, nonconformance reports (NCRs), and formulate and initiate Corrective & Preventive Actions (CAPA) Plans.
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