Andrew Singgih
Principal Quality Assurance Engineer @Adagio Medical Inc.
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WORK HISTORY
Principal Quality Assurance Engineer @Adagio Medical Inc.
Irvine, CA, US
Class Ventricular Tachycardia Catheter:• Managing development of inspection procedures and risk analysis for Class Ventricular Tachycardia Catheter. • Leading sterilization qualifications and validations, ensuring compliance with biocompatibility and sterilization standards. • Collaborated with cross-functional teams to enhance product quality and safety, contributing to operational excellence.
EDUCATION
California State Polytechnic University-Pomona
BSc, Industrial Engineering
Citrus College
Engineering
California State University-Dominguez Hills
Quality Assurance
SKILLS
ABOUT ANDREW SINGGIH
Over 25 years as a veteran Quality professional / leader with multiple American Society of Quality (ASQ) certifications. Quality is a passion as well as the pursuit of Organizational or System excellence. Broad experience in Medical Device, high-tech, defense and commercial industries with technologies in catheter product, wireless product, metal machining, sheet forming, injection molding, and electromechanical assembly. Expertise includes:Project ManagementODM / OEM and Supplier Quality NPI and Offshore Manufacturing Program or Product Quality Planning ISO 9001 and 13485 Quality SystemsSystems Efficiency and ImprovementCorrective and Preventive ActionCustomer Focus / Customer ExcellenceSix Sigma and Process ControlReliability Test Design and ManagementLean Manufacturing
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