Kaveh Moraghebi
Sr. Director of Quality
- Role
- Sr Director of Quality at ALOM
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Kaveh Moraghebi
Highly accomplished quality assurance professional with over 20 years of experience…
Experience
Sr Director of Quality
Sep 2018 — Present · San Francisco, CA, US
Oversee the Quality Assurance and regulatory departments, developing and implementing department goals and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA, and applicable international regulatory bodies.• Responsible for managing and maintaining ISO 9001 and ISO 13485 Quality Management Systems and ensuring compliance with 21 CFR 820 cGMP requirements.• Conduct comprehensive management reviews and annual product/process assessments, ensuring the continual effectiveness and improvement of the Quality Management System (QMS)• Lead external/ compliance audit activities and coordinate and conduct multi-site quality & regulatory internal audits.• Lead and ensure appropriate execution of the supplier assessment, performance evaluation, and qualification process.• Work closely with operation, engineering, and business teams to communicate any problem’s impact using the 8D method & CAPA.• Directed the seamless execution and supervision of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes tailored explicitly for Class 2 medical devices.
Education
Isfahan University of Technology
BS, Mechanical Engineering (Heat & Fluids)
1992 — 1997
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