Sam Lazzara

Sam Lazzara Email and Phone Number

Down Under Head of Quality Assurance @ SDIP Innovations Pty. Ltd.
United States
Sam Lazzara's Location
Fremont, California, United States, United States
Sam Lazzara's Contact Details

Sam Lazzara phone numbers

About Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 40+ years of medical device experience.Sam’s quality systems and documents have delighted over 80 clients, dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 75 firms, leading to third-party certification and government approvals.A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.Learn more at Sam's Blog: http://www.mdqc.com

Sam Lazzara's Current Company Details
SDIP Innovations Pty. Ltd.

Sdip Innovations Pty. Ltd.

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Down Under Head of Quality Assurance
United States
Employees:
11
Sam Lazzara Work Experience Details
  • Sdip Innovations Pty. Ltd.
    Down Under Head Of Quality Assurance
    Sdip Innovations Pty. Ltd.
    United States
  • Mdqc - Medical Device Quality Central
    Mdqc - Medical Device Quality Central
    Fremont, Ca, Us
  • Mdqc - Medical Device Quality Central
    Principal Consultant (Over 80 Clients Served)
    Mdqc - Medical Device Quality Central Aug 2009 - Present
    Fremont, Us
    Medical device quality assurance and regulatory compliance consulting and training. Primary focus is providing tailored quality system document sets and supporting services to client companies based on their specific needs.
  • Concentric Medical (Acquired By Stryker)
    Vp, Qa/Operations
    Concentric Medical (Acquired By Stryker) 2000 - 2009
    Kalamazoo, Mi, Us
  • Corvascular (Technology Acquired By Medtronic)
    Director, Qa
    Corvascular (Technology Acquired By Medtronic) 1998 - 2000
  • Decibel Instruments
    Director, Ra/Qa
    Decibel Instruments 1997 - 1998
  • Symphonix (Acquired By Med-El)
    Director, Ra/Qa
    Symphonix (Acquired By Med-El) 1995 - 1997
    Innsbruck, Tyrol, At
  • Ps Medical (Acquired By Medtronic)
    Quality Manager
    Ps Medical (Acquired By Medtronic) 1992 - 1995
    Minneapolis, Mn, Us
  • Dumed Bv (Acquired By Endosonics And Volcano)
    Quality Manager
    Dumed Bv (Acquired By Endosonics And Volcano) 1990 - 1992
    San Diego, Ca, Us
  • Cr Bard
    Quality Manager
    Cr Bard 1983 - 1990
    Murray Hill, New Jersey, Us

Sam Lazzara Skills

Fda Iso 13485 Quality System Medical Devices Design Control Quality Assurance Regulatory Affairs Technology Transfer Capa V&v Biomedical Engineering Iso 14971 Quality Auditing R&d Manufacturing Validation Gxp Product Launch Glp Gmp Regulatory Submissions Ce Marking U.s. Food And Drug Administration Biocompatibility Sterilization Udi Combination Products International Standards Corrective And Preventive Action Cross Functional Team Leadership Verification And Validation Iso Standards Product Development Research And Development Management

Sam Lazzara Education Details

  • Case Western Reserve University
    Case Western Reserve University
    Biomedical Engineering & Applied Physics
  • Brown University
    Brown University
    Biomedical Engineering
  • Brown University
    Brown University
  • Brown University
    Brown University
    Engineering
  • Brown University
    Brown University
    Engineering

Frequently Asked Questions about Sam Lazzara

What company does Sam Lazzara work for?

Sam Lazzara works for Sdip Innovations Pty. Ltd.

What is Sam Lazzara's role at the current company?

Sam Lazzara's current role is Down Under Head of Quality Assurance.

What is Sam Lazzara's direct phone number?

Sam Lazzara's direct phone number is +151091*****

What schools did Sam Lazzara attend?

Sam Lazzara attended Case Western Reserve University, Brown University, Brown University, Brown University, Brown University.

What skills is Sam Lazzara known for?

Sam Lazzara has skills like Fda, Iso 13485, Quality System, Medical Devices, Design Control, Quality Assurance, Regulatory Affairs, Technology Transfer, Capa, V&v, Biomedical Engineering, Iso 14971.

Who are Sam Lazzara's colleagues?

Sam Lazzara's colleagues are Milad Mehdipour, Iman Manavitehrani, Kevin Mariandry, Setareh Jamalinia, Ficha Quince Cero Uno, Sayedeh Emami Khansari.

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