Andy Howe

Background

About Andy Howe

Bachelor’s Degree in Biology, a Quality System Professional in Document Control with 17 years of Class I, II Medical Devices and Pharmaceuticals including cGMP training. Possess an in-depth ability to evaluate complex problems in both technical and mechanical matters and then develop, initiate and resolve issues in a timely, efficient and cost-effective manner. Demonstrates the ability to organize projects from concept to completion while meeting project deadlines. Additional strengths include: • Multiple Project Management • Technology Troubleshooting • Proven Technical Writing Ability • Solid People & Technical Skills • High Standards of Ethics & Integrity • Adherence to Project Specifications • Understanding of ISO 13485 & 21CFR Pt 820 • FDA, ISO and DEA Regulations Specialty Areas Include Instituting Quality Improvements Proactive Metrics Administration Root Cause Analysis Quality Systems Development & Engineering (FDA CFR Part 820:QSR, CFR Part 211/210/110, Canadian GMP, JPAL, ISO 13485, ISO 9001, ISO 14971, MDD 93/42/EEC) CE Mark Private Label Product (McKesson, Covidien, Medtronics) Managing All Phases of a Product Documentation Life Cycle Multiple Project Management Design control, design verification / design validation /design of qualification Change management. Trend analysis to generate Tracking and Trending Reports Conduct Internal Quality Audits per ISO 13485 and 21 CFR Part 820Aseptic filling ETO/Gamma Sterilization