Jim Craig - Senior Consultant, Quality Assurance

Jim is a Certified Lead Auditor with a long history in the highly regulated, quality-control-conscious aerospace and defense industries. Since 2000, Jim has applied his extensive experience in QMS development and auditing to the medical device industry. He specializes in helped companies develop effective quality management systems that are in full compliance with US, European and Canadian requirements. Documentation development, traceability, internal auditing, Corrective and Preventive Action (CAPA), SOP development and other QA issues are all areas in which Jim has very specific expertise.

Because Jim has worked with so many medical device companies making a wide variety of products, he knows how to tailor quality management solutions to fit the specific needs of the clients he represents.

EXPERIENCE:

Quality Assurance Manager, Spar Aviation Services (1996-1999)

• Responsible for over $70 million in contracts involving repair and service provision at multiple sites.
  
• Designed and implemented ISO quality management systems.
• Implemented effective internal audit programs for software application controls and developed reporting mechanism to identify software deficiencies and required patches.

QA Manager, International Aerospace Management Company (1992-1996)

• Responsible for the $57 million support quality program for the NATO fleet of AWACs E-3A aircraft. This involved all aspects of FAA/JAA regulations as well as ISO 9000 quality system requirements as well as software application controls.
• Monitored and audited subcontractors to ensure that effective software development controls were being used.
• Established acceptance test procedures to ensure that the TPS was effective.

DND Quality Manager, Spar Aerospace (1988-1991)

• Responsible for approximately $100 million in contracts throughout the five divisions of Spar.
• Monitored and audited the support provided on the Space Shuttle remote manipulator arm including all the associated software application controls as well as a rigorous configuration management program which tracked every component on the robotic arm as well as all documentation including software.

DND Quality Manager, Hawker Siddeley Canada Inc. (1986-1988)

• Responsible for government QA on gas turbine engines. Software programs used for automatic test equipment were continuously monitored for effective controls, practices and procedures.

Various positions of increasing responsibility, Canadian Department of National Defence (1971-1986)

• Aircraft support activities, project management, program management, software development, and capital acquisition programs.

AREAS OF EXPERTISE:

Medical Devices:

• Dental
• Diagnostics
• Disposables
  
• Ear, nose and throat
• Hearing aids
• Imaging equipment
• Implants (non-active)
• Mobility aids
• Optical
• Patient monitoring
• Prostheses
• Radiology
• Reusable instruments
• Therapeutics
  
• Surgical instruments

QA & RA:

• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485:2003
  
• Canadian Medical Device Regulations (CMDR)
• Internal auditing for QMS compliance
  

CERTIFICATIONS:

• RAB Registered Quality Management Systems Lead Auditor

EDUCATION:

• B.Sc. in Physics & Chemistry, University of Calgary, Alberta, Canada
• BA in Economics from Queens University, Ontario, Canada

HOME BASE:

• Ontario, CANADA