Bachelor’s degree or higher in a relevant field such as Biology, Microbiology, Chemistry, Biochemistry, Medical Technology, Clinical Medicine, Biomedical Science, Software Technology, Electrical/Electronic/Mechanical Engineering, or Bioengineering.
At least 4 years of experience in the design, manufacturing, testing, or clinical use of In-Vitro Diagnostic (IVD) medical devices, gained in industry, academia, or hospital environments.
Prior experience in auditing and assessment within a Notified Body, particularly in the IVD field, is preferred.
Quality Management System (QMS) auditing experience is desirable; preference given to CCAA-registered QMS auditors.
Strong customer focus with excellent communication and collaboration skills.
Fluent in both written and spoken English.
Capable of managing a high workload and open to frequent travel.