IVD Lead Auditor

Kenton Black; Birmingham; On-site; GBP 40,000 - 70,000

Job description

Job Title: IVD Lead Auditor

Location: Field-based (UK)

Travel: Primarily within the UK (Company car or car allowance provided)

Our client is looking to recruit an Invitro Diagnostics Lead Auditor to plan and conduct audits of in-vitro diagnostic medical devices to EU IVDR (EU Regulation 2017/746).

Key Responsibilities:

1. Conduct on-site audits for clients using established procedures, delivering high-quality service that fosters strong customer relationships.
2. Work independently or lead audit teams, ensuring customer satisfaction and compliance with industry standards and regulatory requirements.
3. Complete all audits and tasks within the set budget and time constraints.
4. Undertake specific projects related to medical device processes, systems, documentation, and procedures, as assigned by the Medical Devices Manager.

Qualifications:

1. Practical experience in the design, manufacturing, or testing of IVD medical devices, with experience in Quality Management System (QMS) or in Quality Management/Regulatory Affairs.
2. A university degree or equivalent qualification in a relevant scientific field, such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science, Biomedical Engineering, Mechanical, Electrical, or Electronic Engineering, or Computer & Software Technology.
3. Familiarity with IVDs and Medical Devices (active, non-active, or software-based) and Medical Device Quality Management Systems.
4. In-depth knowledge of EU IVD Directive 98/79/EC, EU IVD Regulation 2017/746, EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745, UK Medical Device Regulation, and ISO 13485.
5. Understanding of relevant IVD and Medical Device Standards.