Katherine Mason

About Katherine Mason

Accomplished Quality Manager and Quality Engineer specialized in developing Design…

Experience

1. Senior Quality Engineer and Quality Management Representative

   Delve

   Nov 2020 — Present · Madison, WI, US

   Driving Force and author of a new ISO 13485 Compliant Quality Management System for the Design and Development of Medical Devices where there was no previous Quality Management System. • Championed and authored IEC 62304 Software Development and Cybersecurity procedures.• Drove Best Practices for Product Realization and Design Control Records for Medical Devices. • Championed and authored ISO 14971 procedures and creation and Management of ISO 14971 Risk Management Files.• Led the Creation and Management of Design History Files (DHF) for Medical Devices both within Delve’s Quality System and clients Quality Systems. • Provided Consultation and Guidance for Medical Device Manufacturer Clients that ranged from early-stage startups to Large Corporations on the Quality Process as it applies to the product development process from conception to production.• Leading multi-disciplinary teams (Management, Marketing, Design, Engineering, V&V, and Manufacturing) in quality of Medical Device Development Documentation.• Training staff and clients on Delve’s QMS, ISO 13485, FDA 21 CFR 820, ISO 14971, and IEC 60601 through presentations to audiences of 1 to 200. • Enthusiastic Partner with Strategic Marketing to Quote and Present complex proposals to C-Suite executives on projects up to $5million.• Conducting Internal and External Supplier Audits.• Leading External Audits with 100% Passage.• Implemented and used JAMA for requirements management, risk management, and test management

Education

• The Ohio State University

  Bachelor of Science (B.S.)

  2002 — 2007