Our Team of Auditors
Comply Guru’s experienced team of Lead Auditors regularly train auditors for Regulators, Notified Bodies, Registrars & Certification Bodies, Consultants as well as Industry. Very few organizations in the world can say the same. Our team is available to provide a range of contract auditing services to help you or your company. Get in touch with us today to discuss your needs!
Michelle Keane
QA/RA Director
Michelle has a proven track record with over 20 years’ experience working across both the Medical Device and Biotechnology sectors.
Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for .
Tess Egan
MD-QMS Lead Auditor
Tess is a former Regional Compliance Auditor for Abbott Rapid Diagnostics Division responsible for the planning and execution of independent Regional Compliance audits for Divisional regulated entities in the EMEA region.
In addition, Tess performed audits in the APAC & Americas as well as third party supplier audits globally. In a career spanning over 20 years, she has vast experience with global regulations across the Globe including GMP, GLP, GCP, GcLP, GDP, ISO 13485, ISO 9001, and ISO/IEC 17025.
As an Instructor, Tess brings a passion for training & auditing to every live workshop she leads.
Kristian Hill
QEHS Lead Auditor
Kristian has over 20 years’ experience and is formally registered as a CQI & IRCA Lead Auditor for both ISO 9001:2015 & ISO 45001:2018, as well as registered with IEMA as a Principal Environmental Auditor.
Kristian currently offers Assessment, Consultancy and Training across various business sectors, specializing in the implementation and integration of management systems with particular reference to key business themes such as quality, environment, energy, occupational health and safety, leadership and management.