Principal Supplier Quality Engineer
CurrentSupplier Quality Engineer supporting Next-Gen delivery system for Transcatheter Heart Valve replacement devices
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@edwards.com
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Ash K. is listed as Expert in Class III Medical Device Quality & Supplier Management | Lean Six Sigma Black Belt at Edwards Lifesciences, based in Chino, California, United States. AeroLeads shows a work email signal at edwards.com and a matched LinkedIn profile for Ash K..
Ash K. previously worked as Principal Supplier Quality Engineer at Edwards Lifesciences and Sr Engineer - Quality (Pilot) at Edwards Lifesciences. Ash K. holds Master'S Degree, Metallurgical Engineering & Materials Science With Specialization In Process Engineering from Indian Institute Of Technology, Bombay.
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With a passion for driving quality and process improvement in the healthcare industry, I am an ASQ Certified Quality Engineer and Six Sigma/Lean Black Belt professional. With a background in metallurgical engineering and material science, I bring over three years of experience in the steelmaking industry and over seven years in the biomedical sector.Currently serving as a NPD Supplier Quality Engineer for next gen delivery system components in Heart Valve Replacement devices, I am dedicated to ensuring the delivery of outstanding quality products that cater to the critical needs of human healthcare. My specialties include creative problem solving, NCR / CAPA investigation, risk management, design assurance, supplier management and test method development. My core competency lies in collaborative working, built on the foundation of strong relationship with cross-functional teams, suppliers, and stakeholders.My proficiency extends to Lean transformation methodologies such as labor analysis, value stream mapping, and kaizen, as well as Six Sigma methodologies including DMAIC, DOE, and hypothesis testing. I am adept in statistical process control, mistake-proofing, new product development and creative problem-solving.Currently pursuing Six Sigma Master Black Belt certification, I am committed to continuous learning and professional development to further contribute to organizational success and advancement in healthcare quality.
Listed skills include Materials Science, Metallurgy, Management, Engineering, and 12 others.
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Irvine, CA, US
Supplier Quality Engineer supporting Next-Gen delivery system for Transcatheter Heart Valve replacement devices
Irvine, CA, US
- Serving as a Quality Engineering Lead, driving advancements in Next-Gen Mitral Valve Replacement/Repair Devices.- Directed continuous improvement initiatives, overseeing test method development and establishing critical control points.- Orchestrated production ramp-up strategies and facilitated seamless transitions of products to commercial manufacturing.
Irvine, CA, US
- Led NCR Investigations to address and resolve issues swiftly and effectively.- Implemented Change Management strategies to streamline processes and enhance efficiency.- Managed Corrective and Preventive Action (CAPA) procedures to ensure regulatory compliance and product quality.- Applied knowledge of 21 CFR 820 and ISO 13485 standards to uphold.
IN
Mumbai, Maharashtra, IN
Built Library Management System for department library using PHP and HTMLAssisted professors with teaching, assessment activities and practical work directed towards delivery of course work at under graduate level
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Ash K. works for Edwards Lifesciences.
Ash K. is listed as Expert in Class III Medical Device Quality & Supplier Management | Lean Six Sigma Black Belt at Edwards Lifesciences.
AeroLeads has found 1 work email signal at @edwards.com for Ash K. at Edwards Lifesciences.
Ash K. is based in Chino, California, United States while working with Edwards Lifesciences.
Ash K. has worked for Edwards Lifesciences, Steel Authority Of India Limited, and Indian Institute Of Technology, Bombay.
You can use AeroLeads to view verified contact signals for Ash K. at Edwards Lifesciences, including work email, phone, and LinkedIn data when available.
Ash K. holds Master'S Degree, Metallurgical Engineering & Materials Science With Specialization In Process Engineering from Indian Institute Of Technology, Bombay.
Ash K. is listed with skills including Materials Science, Metallurgy, Management, Engineering, Leadership, Operations Management, Commissioning, and Six Sigma.
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