Quality Systems Manager
As Quality Systems Manager and Management Representative, Cheryne supports medical device companies by aiding in setting up new quality systems that are intended to be ISO certified and QSR compliant
Cheryne also acts as internal auditor for clients, auditing their quality systems to various regulations including ISO 13485, ISO 14971, QSR, MDD, and Canadian Medical Device Regulations.
Cheryne’s background and experience covers more than twenty years in the medical device industry in a variety of roles, specializing in Quality Systems Management. She has worked very closely with medical device companies in maintaining and supporting their Quality System requirements and compliance with ISO standards and FDA’s Quality System Regulations.
Cheryne’s previous experience includes positions at TDC Medical, NDO Surgical, Smith & Nephew, Endoscopy Division, Acufex Microsurgical and Augat. In addition to Quality Assurance roles, Cheryne has held product development engineering positions and has been trained as a lead auditor. Her experience also includes management representation at companies who held ISO/CMDCAS certificates, as well as EC certificates for CE Marked product.
Cheryne received a Bachelor of Science in Mechanical Engineering from Syracuse University.