Focused, quality-driven senior engineer and manager with 20+ years of experience in Quality Engineering, Design to Production Transfer, Process Engineering & Process / Product Validation. Highly skilled at working within diverse manufacturing environments. Knowledgeable in ISO 13485, FDA 210, 211, 820 and skillful at developing methodologies to ensure adherence to Good Manufacturing Processes (GMP).
Proven ability to build and lead teams of engineers and technicians. History of building productive relationships with manufacturers, employees and management from diverse backgrounds. Expert technologist, with expertise in the design, manufacturing, implementation and support of sophistica...
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