Sam Lazzara
Principal Consultant (over 80 clients served) at MDQC - Medical Device Quality Central | Fremont, California, United States
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Sam Lazzara is a seasoned Principal Consultant at MDQC - Medical Device Quality Central, where he leverages over 40 years of extensive experience in the medical device industry to provide unparalleled quality assurance and regulatory compliance consulting. With a robust educational background, holding a Master’s degree in Biomedical Engineering from Case Western and a Bachelor’s degree from Brown University, Sam has honed his expertise in quality systems, design control, and regulatory submissions. His role involves crafting tailored quality system document sets that align with the unique needs of each client, ensuring they meet stringent standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the California Department of Health.
Throughout his career, Sam has successfully served over 80 clients, delivering quality systems and documentation that have not only satisfied regulatory auditors but have also enhanced the operational efficiency of client companies. His deep understanding of Good Laboratory Practices (GLP), validation processes, sterilization methods, and Unique Device Identification (UDI) requirements positions him as a trusted advisor in the medical device sector.
Key projects under Sam’s leadership have included comprehensive training programs designed to elevate client teams' understanding of quality assurance processes and regulatory compliance, ultimately fostering a culture of excellence in product development. His commitment to client success, combined with his ability to navigate complex regulatory landscapes, makes him an invaluable asset to MDQC and the medical device industry at large. Sam’s passion for biomedical engineering and quality assurance continues to drive innovation and compliance in the ever-evolving landscape of medical technology.
Principal Consultant (over 80 clients served) at MDQC - Medical Device Quality Central in August 2009 to Present
VP, QA/Operations at Concentric Medical (acquired by Stryker) in January 2000 to January 2009
Director, QA at Corvascular (technology acquired by Medtronic) in January 1998 to January 2000
Director, RA/QA at Decibel Instruments in January 1997 to January 1998
Director, RA/QA at Symphonix (acquired by MED-EL) in January 1995 to January 1997
Quality Manager at PS Medical (acquired by Medtronic) in January 1992 to January 1995
Quality Manager at DuMED BV (acquired by Endosonics and Volcano) in January 1990 to January 1992
Quality Manager at CR Bard in January 1983 to January 1990
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FDA
ISO 13485
Quality System
Medical Devices
Design Control
Quality Assurance
Regulatory Affairs
CAPA
V&V
Biomedical Engineering
ISO 14971
Quality Auditing
R&D
Manufacturing
GLP
GMP
Validation
Regulatory Submissions
CE marking
Biocompatibility
Sterilization
Combination Products
UDI
International Standards
Technology Transfer
GxP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Verification and Validation (V&V)
Product Development
Research and Development (R&D)
Product Launch
ISO Standards
Management
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Discover more about MDQC - Medical Device Quality CentralWhat is Sam Lazzara email address?
Email Sam Lazzara at [email protected]. This email is the most updated Sam Lazzara email found in 2026.
What is Sam Lazzara phone number?
Sam Lazzara phone number is +15103661767 and +15109182810.
How to contact Sam Lazzara?
To contact Sam Lazzara send an email to [email protected]. If you want to call Sam Lazzara try calling on +15103661767 and +15109182810.
What is Sam Lazzara net worth?
Sam Lazzara has an estimated net worth of $375,000 to $499,999
What company does Sam Lazzara work for?
Sam Lazzara works for MDQC - Medical Device Quality Central
What is Sam Lazzara's role at MDQC - Medical Device Quality Central?
Sam Lazzara is Principal Consultant (over 80 clients served)
What industry does Sam Lazzara work in?
Sam Lazzara works in the Business Consulting And Services industry.
Sam Lazzara Email Addresses
Sam Lazzara Phone Numbers
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