Quality Systems & Regulatory Compliance
Marcia M. Weeden, MS
Founder and Principal Consultant
Marcia Weeden has worked in quality and regulatory compliance for more than three decades — across Defense, automotive, consumer products, medical devices, and pharmaceuticals. She began as a quality assurance representative for the Defense Contract Administration Services, directed quality assurance at Duro Industries and at Eden Toys, and has since built quality systems and regulatory documentation for Pfizer, DePuy (Johnson & Johnson), Huestis Medical, Aidance Scientific, and CertainTeed.
She led the investigation that overturned a $7 million Defense rejection, qualified three in-house laboratories for the Defense Personnel Support Center's Qualified Laboratory List, and wrote Failure Mode and Effects Analysis for Small Business Owners and Non-Engineers for ASQ Quality Press.
Focus
- ISO 9001, ISO 13485, and FDA QMSR Quality Systems
- EU MDR 2017/745 Technical Documentation
- CAPA, Root Cause, and FMEA
- Auditing to ISO 19011; Laboratories to ISO/IEC 17025
- SOPs, Technical Writing, and Training
MS, University of Rhode Island · ASQ Certified Quality Engineer · ASQ Certified Quality Technician