Hany A.
Site Quality Lead Rebound Therapeutics - Integra Lifesciences
- Role
- Site Quality Lead at Integra LifeSciences
- Location
- Menlo Park, CA, US
- LinkedIn followers
- 500 followers
About Hany A.
Six Sigma Black Belt and ASQ certified professional with over 30 years of experience in product and process development quality engineering, exclusively within the medical device and diagnostic instrumentation industry. In depth background working with FDA “Quality System Regulations”, ISO-13485/ISO-9001 standard, European Medical Device Directives and various US and international electrical safety standards. Diverse product and process quality development engineering and project management experience including validation for; manufacturing, product & process development, technology transfer, design control & prototyping. Development of comprehensive quality master plans for new products and processes including; R&D, receiving, manufacturing logistics, material planning, testing, computer and automated process control systems.ASQ: Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE); SME: Certified Manufacturing Engineer (CMfgE), Certified Engineering Manager (CEM).Specialties: Medical device new product development quality and reliability engineering.
Experience
Site Quality Lead
Apr 2024 — Present
Oversee quality systems, manufacturing quality, and quality compliance
Education
California State University, Fullerton
Bachelor of Science - BS, Electrical Engineering
California State University-Dominguez Hills
Master of Science - MS, Quality Assurance
Eastern Michigan University
Master of Science - MS, Engineering Management
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