Back to searchIVD Lead Auditor
Kenton Black - Science & Engineering
Posted 2 days ago, valid for a month
Birmingham, West Midlands B4 6FQ
£35,000 - £42,000 per annum
Full Time
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Sonic Summary
- The position of IVD Lead Auditor is field-based in the UK, requiring travel primarily within the country, with a company car or car allowance provided.
- The role involves planning and conducting audits of in-vitro diagnostic medical devices to ensure compliance with EU IVDR regulations.
- Candidates should have practical experience in the design, manufacturing, or testing of IVD medical devices, along with a relevant university degree or equivalent qualification.
- In-depth knowledge of EU regulations and standards related to medical devices is essential, as well as experience in Quality Management Systems.
- The job offers a competitive salary, and candidates are expected to have several years of relevant experience in the industry.
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.
