Anthony Guazzo Email Address

Senior Manager, Corporate Quality Systems

Nypro, a Jabil company, specializes in mechatronic components and products for healthcare markets, as well as plastic injection molding, mold-making, and tooling.

Skills & Experience: Successful leadership and management experience in QA/RA functions: • Reduced product complaints by 40% through data analysis and aggressive focus on CAPA. • Eliminated root causes of significant product quality issues through 8D & PDCA leadership. • Reduced Corporate Compliance audit findings from 30 to 1. • Successfully licensed & registered medical devices under worldwide regulatory requirements. Effective cross-functional implementation of broad-based strategic plans: • Authored and led implementation of a global improvement plan that successfully addressed multiple gaps in the division’s quality and regulatory performance, including: Supplier Controls, Technology & Capital Investment, Systems & Processes, Organizational Structure, Performance Management, Rewards & Recognition and Success Monitoring. Customer-oriented application of quality principles to a variety of manufacturing operations, including: • Injection Molding, Metal Working & Grinding, Chemical Batch Formulation, Food Preparation, Laboratory Analysis, Labeling & Printing and Manual Assembly. Solid technical skills obtained through a combination of education and work experience: • Problem Solving with Root Cause Analysis techniques (based in 8D / PDCA) and Design Control. • SPC / SQC, Hypothesis Testing, ANOVA, Experimental Design, and Process & Software Validation. • Medical device regulatory submissions including 510(k), PMA, Canadian License, and CE Certification. • Experienced in FDA, ISO, and PAL (Japan) audit environments, including audit preparation, conduct, and providing formal response to reports and findings (e.g., FDA 483). Specialties: Quality Systems Development / Auditing, Strategic Planning, Project Management / Team Leadership, Root Cause Analysis (RCA), Corrective & Preventive Action (CAPA), Complaint / Nonconformance Investigation, Product Development Support, Quality Control Management, Experimental Design, Process / Software / Design Validation, Statistical Analysis