About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

About the role

Take ownership of achieving personal KPI targets in alignment with team and organizational goals.
Perform ISO 13485 and IVDR audits and assessments efficiently and competently, in accordance with CE regulations, international standards, applicable regulatory systems, and the company’s certification programs.
Ensure all work is carried out with the highest level of independence, integrity, and professionalism.
Support continuous improvement by identifying and implementing enhancements to audit processes, information handling, and cross-functional collaboration within the organization.
Plan, organize, and deliver various client projects, including assessments, gap analyses, trainings, and customer workshops.
Maintain active auditor/assessor registration and qualifications to perform designated duties.
Undertake additional tasks as assigned by the Line Manager.

About You

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.