Deborah Madsen has been working as a Qa and Ra Director in Biophotas, Inc. since 2016. Additionally, Deborah has professional experience at more than eight companies in the related field. Deborah has a total work experience of 31+ years. Deborah Madsen studied at the University of Illinois at Urbana - Champaign from 1980 to 1985. Deborah has the following certificates: License Sf3331, License M-1295, Registered Professional Engineer, and Cmdcas Auditor. Nowadays they live in Los Angeles, California region. Find this expert's current email address and number with our search.
Name variants:
Debbie Madsen,
Debby Madsen,
Debra Madsen,
Deb Madsen
Last updated May 01, 2024
Contact Information
Workplace
Qa and Ra Director
Tustin, CA
Industry
Medical Devices, Nonclassifiable Establishments, Whol Medical/Hospital Equipment
Colleagues
Work History
Independent Reviewer and Quality Representative
Subject Matter Expert in providing Software Quality Assurance and general Regulatory Advice in technical product development projects. Performing independent reviewer role in design history ...
from Mar 2016
Director of Quality Assurance
845 Embedded Way SUITE 150, San Jose, CA 95138
Implemented and maintained the quality management system in accordance with ISO 13485
Qualified and monitored suppliers, oversaw document control process and regulatory submittals
Maintai...
Apr 2015 — Mar 2016
Staff Engineer and Lead Auditor
333 Pfingsten Rd, Northbrook, IL 60062
Conducted audits of medical device manufacturers in accordance with ISO 9001, ISO 13485, CMDR, MDD, IVDD, IMMETRO and JPAL.
Developed test plans based on familiarity with medical and clini...
2000 — Jul 2007
Staff Engineer
250 south Kraemer Blvd, Brea, CA 92821
Held responsibility for international standards development, lab supervision, product safety assessments, obtaining EU regulatory clearances, internal auditing, and participating in design a...
1991 — 1999
Senior Project Engineer, Engineering Team Leader
333 Pfingsten Rd, Northbrook, IL 60062
Led team of ten engineers and technical writers in product categories of medical and dental equipment for laboratory and personal hygiene and healthcare. Conducted product safety evaluations...
1985 — 1991
Education
1980 — 1985
Occupations
Journalist
Reviewer
Accountant
Controlling Specialist
Representative
Executive
Director
Subject Matter Expert
IT Professional
Software Tester
Controller
Operations Manager
Skilled Professional
Computer Specialist
Skills
Iso 13485
Medical Devices
Quality System
Iso 14971
Iec 60601
Product Safety
Validation
Ce Marking
Design Control
Product Certification
Iso
Medical Device Directive
Iso 9000
Iec
Quality Assurance
Root Cause Analysis
Quality Management
Capa
Auditing
Regulatory Affairs
Engineering
Testing
Cmdcas
Regulatory Requirements
Standards Compliance
V&V
Quality Auditing
Iso 17025
Electrical Engineering
Regulations
Quality Control
Fmea
R&D
Standards Development
Safety Engineering
Failure Analysis
Supplier Quality
Corrective and Preventive Action
Ivdd
Iso Standards
Verification and Validation
Research and Development
Failure Mode and Effects Analysis