Operations Quality Manager, Abbott Diagnostics
Mr. Muegge’s experience has been focused on FDA and related regulated environments for pharmaceuticals, consumer products, and medical devices. Specific areas of work have included:
– Quality Systems
– Process Re-engineering
– Project Management
– Product Development Life Cycle (R&D through Launch)
• Helped prepare a medical device site for their first FDA inspection. The inspection was successful with the inspector stating without implementing the changes I drove, the inspection would have failed.
• Led efforts in several PPC (Production and Process Controls) areas related to outsourcing of manufacturing to Asia for several flagship products. My contributions were recognized by the upper executives asking that I help lead the efforts in these same areas for other sites and products.
• Harmonized validation activities globally across seven sites resulting in increased standardization and decreased compliance risk.
• Audited quality systems of strategic partners making final recommendations and building relationships resulting in strategic business alliances for faster study completion.
• Managed the quality and compliance group for a key department with direct exposure to FDA and related regulatory body inspections resulting in no deficiencies during regulatory inspections.
• Recognized as a quality and compliance subject matter expert in automated systems and validation resulting in three industry awards, influenced industry trends, and successfully passing audits by the FDA and other regulatory agencies.
• Reduced complexity of key processes by 50% through process analysis and process re-engineering resulting in straightforward processes, clearer accountability, and increased quality.