Donna Campbell

Donna Campbell Email and Phone Number

Regulatory / Quality Medical Device Professional @ Viscus Biologics LLC
Donna Campbell's Location
Cleveland, Ohio, United States, United States
Donna Campbell's Contact Details

Donna Campbell personal email

n/a

Donna Campbell phone numbers

About Donna Campbell

Accomplished and result driven professional offering broad-based experience in quality and manufacturing. Over 20 years’ experience in highly regulated industries and 15 years in the medical device industry. Extensive knowledge of good manufacturing, FDA, ISO 13485 / 14001 / 9001, Medical Device Single Point Audit (MDSAP) program, MDD, MRD, IVDD, IVDR, CMDR (Canada), and RDC 16 (Brazil) requirements., and ISO 9001 requirements. Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.Experience with all aspects of Quality Management Systems for Medical Device.:  Quality Management System Development and Maintenance Development Internal and Supplier Audit Programs Supplier/Contract Management Deviation/Nonconformance and Root Cause Analysis Corrective Action Preventive Action (CAPA)  Procedure Development Tracking and Analyzing key performance indicators, metrics, and trend analysis Risk Analysis Management  Document / Change Control Systems Continuous Improvement Product Development and Design Control Process Validation & Equipment Qualification Develop Training Customer Complaints Handling Adverse Event Reporting Development of Quality Manuals QC Analytical Testing, Incoming Inspection Product Label Approval Overall Medical Device Requirements

Donna Campbell's Current Company Details
Viscus Biologics LLC

Viscus Biologics Llc

View
Regulatory / Quality Medical Device Professional
Donna Campbell Work Experience Details
  • Viscus Biologics Llc
    Director Of Quality And Regulatory
    Viscus Biologics Llc Sep 2023 - Present
    Cleveland, Oh, Us
    View
  • Bsi
    Senior Client Manager
    Bsi May 2019 - Oct 2023
    London, Gb
    View
  • Maetrics
    Sr. Capa Engineer
    Maetrics Sep 2017 - May 2019
    Monroeville, Pa, Us
    View
  • Fluke Corporation
    Ra/Qa Manager
    Fluke Corporation Jun 2016 - Sep 2017
    Everett, Wa, Us
    View
  • Qure Medical
    Quality Manager
    Qure Medical Mar 2015 - Apr 2016
    Pepper Pike, Ohio, Us
    View
  • Regulatory And Quality Solutions Llc (R&Q)
    Regulatory & Quality Principal
    Regulatory And Quality Solutions Llc (R&Q) Jul 2014 - Mar 2015
    Monroeville, Pa, Us
    View
  • Department Of Veterans Affairs
    Quality Assurance Manager
    Department Of Veterans Affairs May 2013 - Jul 2014
    Washington, Dc, Us
    View
  • Affymetrix
    Sr. Qa Engineer/Supervisor
    Affymetrix Oct 2008 - Feb 2013
    Santa Clara, California, Us
    Managed staff of 3 Quality Inspectors supporting production employees. Led site wide quality improvement initiatives and training.
    View
  • Cleveland Medical Devices
    Quality Assurance/Ra Manager
    Cleveland Medical Devices Oct 2007 - Oct 2008
    Cleveland, Ohio, Us
    Led companywide quality system development implementation and training.
    View
  • American Red Cross
    Operations Supervisor
    American Red Cross Aug 1999 - Sep 2007
    Washington, Dc, Us
    Managed Operations support department with staff or 6-8 employees. Managed equipment, validation, records and document control systems. Achieved team effectiveness by demonstrating and encouraging openness and honesty among employees, increasing communication and productivity.
    View

Donna Campbell Skills

Quality System Quality Assurance Capa Iso 13485 Medical Devices Validation Quality Management Quality Control Fda Iso Manufacturing Quality Auditing Root Cause Analysis Gmp Continuous Improvement Cross Functional Team Leadership Manufacturing Operations V&v Process Improvement Fda Gmp Operational Excellence Lean Manufacturing Spc Supplier Quality Dmaic Six Sigma Design Control Fmea Biotechnology Regulatory Affairs Iso 9000 Design Of Experiments Change Control Value Stream Mapping 5s R&d Process Engineering Calibration Iso 14971 Software Documentation Kaizen Minitab Glp Technology Transfer Process Simulation Testing Team Building Facilitation Sop Strong Business Acumen

Donna Campbell Education Details

  • Indiana Wesleyan University
    Indiana Wesleyan University
    Management
  • Lccc
    Lccc
    Medical Technology

Frequently Asked Questions about Donna Campbell

What company does Donna Campbell work for?

Donna Campbell works for Viscus Biologics Llc

What is Donna Campbell's role at the current company?

Donna Campbell's current role is Regulatory / Quality Medical Device Professional.

What is Donna Campbell's email address?

Donna Campbell's email address is ca****@****usa.com

What is Donna Campbell's direct phone number?

Donna Campbell's direct phone number is (408)-731*****

What schools did Donna Campbell attend?

Donna Campbell attended Indiana Wesleyan University, Lccc.

What are some of Donna Campbell's interests?

Donna Campbell has interest in Management/leadership Training, Motivation, Running, Improvement, Quality, Greyhounds.

What skills is Donna Campbell known for?

Donna Campbell has skills like Quality System, Quality Assurance, Capa, Iso 13485, Medical Devices, Validation, Quality Management, Quality Control, Fda, Iso, Manufacturing, Quality Auditing.

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