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IVD Lead Auditor

Kenton Black Ltd

Birmingham

Remote

GBP 40,000 - 80,000

Full time

25 days ago

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An established industry player is seeking a skilled Invitro Diagnostics Lead Auditor to join their dynamic team. In this pivotal role, you will be responsible for planning and conducting audits of in-vitro diagnostic medical devices, ensuring compliance with EU regulations and industry standards. Your expertise in Quality Management Systems and regulatory affairs will be crucial as you work independently or lead audit teams, fostering strong relationships with clients. This position offers a unique opportunity to influence the quality assurance processes within a growing sector while enjoying the benefits of a field-based role with travel across the UK. If you are passionate about quality and compliance in the medical device industry, this opportunity is perfect for you.

Company car or car allowance

Travel opportunities within the UK

Practical experience in IVD medical devices and Quality Management Systems.
University degree in Chemistry, Biology, or related field required.

Conduct on-site audits ensuring compliance with industry standards.
Lead audit teams and manage customer satisfaction throughout the process.

Auditing Skills

Quality Management Systems (QMS)

Regulatory Affairs

Customer Relationship Management

University degree in relevant scientific field

Equivalent qualification in scientific field

ISO 13485

EU IVD Regulation 2017/746

EU Medical Device Regulation 2017/745

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:

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

Qualifications:

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.
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.
Familiarity with IVDs and Medical Devices (active, non-active, or software-based) and Medical Device Quality Management Systems.
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.
Understanding of relevant IVD and Medical Device Standards.

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