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Gary Scalise - Senior Consultant, Quality Assurance and Regulatory

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Gary Scalise is a certified International Lead Auditor and is responsible for assisting Emergo's medical device and IVD clients with the development, implementation, and auditing of quality and regulatory systems in accordance with FDA QSR, ISO 13485:2003 and Canadian Medical Device Regulations.

Gary is highly experienced and registered to audit medical device, IVD and pharmaceutical companies. He has been a practicing ASQ certified quality engineer since 1979 and a CQE instructor for 20+ years. Gary serves clients in the eastern United States.

EXPERIENCE:

  • Director, Quality Assurance, Communications Instruments, Inc.  (1991)
  • Engineering Instructor, EATON Research Center (1988)
  • Quality Manager and Engineer, GTE Products Corp., Electronic Materials Group (1978-1988)
  • Research Engineer, Interlectric Corp. (1976-1978)

AREAS OF EXPERTISE:

Medical Devices:
  • Ambulatory monitoring
  • Aseptic filling
  • Clean rooms
  • Dental and orthodontics
  • Diagnostics
  • Disposable plastics devices
  • Eye-care
  • Filters, blood and ventilator
  • Hearing aids
  • Imaging equipment
  • Implants, passive devices
  • Infusion pumps and IV sets
  • In vitro diagnostics
  • Medical grade polymers
  • Optical
  • Patient monitoring
  • Prostheses and fixation devices
  • Radiology
  • Reusable devices
  • Sterile devices and sterilization protocol
  • Surgical instruments
  • Ultrasonic monitors
  • Wound dressings
QA & RA:
  • CE Marking
  • MDD 93/42 and 2007/47 and 98/79
  • FDA Quality System Regulation / QSIT / cGMP
  • FDA MDR 21CFR803-804
  • ISO 13485
  • Canadian Medical Device Regulations (CMDR)
  • ISO 14971 Risk Management
  • EN-60601 Electrical Devices Safety Regulations
  • ISO-19011 Quality System Auditing
  • ISO-17025:2005 Laboratory Accreditation
  • ISO-15189 Clinical Laboratory Accreditation
  • GLP 58 Good Laboratory Practices
  • Process Validation and Capability Studies
  • ISO-9001:2000 Quality Management
  • J-PAL Japanese Pharmaceutical Affairs Law
  • SPC and Statistical Problem Solving

CERTIFICATIONS:

  • IRCA QMS 2000 Principal Auditor #A04233 (1994)
  • RAB/QSA QMS Lead Assessor #Q01710 (1995)
  • ASQ Certified Quality Engineer #9382 (1982)
  • ASQ Certified Quality Manager #2922 (1998)
  • American Society for Quality Senior Member #055035 (1981)
  • BSI/CEEM Certified EMS Lead Auditor, #0410US (2000)
  • BSi Management Systems Certified Lead Assessor, QMS
  • BSi Management Systems Certified Instructor & Qualifier
  • Certified Assessor, Japanese Pharmaceutical Affairs Law
  • Certified Professional Photographers of America

CERTIFICATIONS:

  • RAB and IRCA, International Register of Certificated Auditors
  • Registered Quality Management Systems Lead Auditor
  • ANSI-RAB Registered Quality Management Systems Lead Auditor qualified to ISO 9001:2000
  • Technical Lead Assessor, American Association for Laboratory Accreditation.

EDUCATION:

  • Masters degree in Industrial Technology, Western Carolina University
  • Bachelor degree in Broadcast Communications, Temple University
  • Electrical Engineering, Drexel University

HOME BASE:

  • North Carolina, USA