Kimberly A. Cunningham
President/Connecticut ISO Quality Consultant
Kim has over 17 years of experience in quality as a Manufacturing Engineer, Quality Manager, and Quality Consultant. She has a broad spectrum of experience with multiple standards and regulations across various industries. Kim has strong working knowledge of the medical device and aerospace industries with experience auditing to ISO 9001, ISO 13485, AS9100, ISO 14001, and applicable regulatory requirements.
Kim has implemented and improved Quality Management Systems with numerous companies. Her work has included documentation development, training, process mapping, process validation, internal auditing, supplier auditing, guidance through certification process, and on-going maintenance.
Kim’s background and experience includes:
• ISO9001, ISO13485, ISO14971, ISO14001, and AS9100 implementations and certifications
• Internal auditing and training to the ISO9001, ISO14001, AS9100, ISO13485, FDA CFR Title 21 Part 820 and 211, Medical Device Directive (93/42/EEC), IVDD (98/79/EC), Canadian Medical Device (CMDR), and GMP requirements
• Process improvements utilizing Facilitator skills and Value Stream Mapping
• Supplier auditing for the pharmaceutical and implantable medical device industries
• Experience with various industries, such as: Aerospace, Analytical Instrument, Alternative Energy, Automotive, Defense, Distribution, Hospital, Medical Device, Pharmaceutical, and Metal Fabrication
• Bachelor’s degree in Chemical Engineering (University of Connecticut 1999)
Kim’s manufacturing background and problem-solving skills complement her quality experience in evaluating companies and identifying areas of improvement. Her skills as a facilitator help companies make those improvements.