Quality Assurance Specialist – IVD / Medical Devices

Cypartners; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading MedTech company in London is seeking a Quality Assurance Specialist for a 12-month contract. This role involves managing documentation and ensuring compliance with ISO 13485 standards. Ideal candidates will have experience in Quality Assurance or Document Control within medical devices, along with strong IT skills. Excellent communication is essential for collaborating with stakeholders. The position offers a competitive salary and the chance to work with a pioneering diagnostics platform.

Qualifications

• Prior Document Control or Quality Assurance experience in medical devices.
• Understanding of medical device regulations such as ISO 13485 and 21 CFR Part 820.
• Experience with electronic Document and Quality Management Systems.

Responsibilities

• Manage controlled documentation to ensure compliance.
• Support QA team in document preparation and distribution.
• Ensure upkeep of the Quality Management System (QMS).

Skills

Document Control

Quality Assurance

Attention to Detail

Communication Skills

Education

Degree in a scientific discipline

Tools

Microsoft Office

Electronic Document Management System (eDMS)

Electronic Quality Management System (eQMS)

Job description

Quality Assurance Specialist – IVD / Medical Devices

12 month contract

Based in London

£ Highly competitive salary

Do you have experience supporting Quality Assurance activities within a medical devices, diagnostics, or biotechnology organisation?

Would you like to join the quality assurance team at a ground-breaking medical diagnostics organisation, who are at a really exciting stage of product development?

My client are a well-funded and trail‑blazing MedTech company with a disruptive diagnostics platform, providing fast and insightful near‑patient analysis for a range of unmet clinical needs. With an international presence, my client has already enjoyed commercial success from their technology and has a strong product development pipeline. As they continue to grow, they are looking to bring onboard a Quality Assurance Specialist – IVD / Medical Devices, who will play a key role in maintaining the Quality Management System (QMS), supporting manufacturing processes, and ensuring compliance with regulatory standards such as ISO 13485.

Key Responsibilities

• Manage controlled documentation, ensuring compliance with company policies, procedures and regulatory guidelines.
• Support the QA team and wider business in ensuring documents are prepared, reviewed, updated and distributed or stored within agreed timelines.
• Ensure upkeep of the Quality Management System (QMS).
• Maintain and organise the document control database, ensuring documents are accurate, up to date and easily accessible.
• Comply with strict document control protocols, identifying and actioning areas of improvement.
• Deliver training and provide support to colleagues for QA and document control activities.
• Act as the point of contact for external stakeholders in relation to document control activities.
• Ensure documentation is organised and stored in compliance with medical device regulations e.g. ISO 13485 and 21 CFR Part 820.

Qualifications

• Prior Document Control or Quality Assurance experience, preferably from within a medical devices, diagnostics or biotechnology organisation.
• A demonstrable understanding of medical device regulations and requirements e.g. ISO 13485 and 21 CFR Part 820.
• Strong IT skills, with a proficiency using Microsoft Office and similar software packages.
• Experience with an electronic Document Management System (eDMS) and/or electronic Quality Management System (eQMS) would be highly advantageous.
• A keen eye for detail to be able to identify documentation abnormalities and take steps to address these.
• Excellent communication skills and a personable nature to support relationship building with both internal and external stakeholders.
• Ability to work both independently and within the larger organisation team to ensure the smooth running of documentation activities.
• A degree (or equivalent working experience) in a scientific discipline such as Biology, Molecular Biology, Chemistry, Biotechnology or a related area. In the absence of a degree, A-Levels or equivalent will be considered.

For further information, please apply online or contact Katie‑May Kress at CY Partners for further information.

Key Words

“Quality Assurance Specialist, Quality Assurance, QA, QMS, ISO 13485, 21 CFR 820, Document Control, CAPA, Nonconformance, Change Control, Manufacturing QA, IVD, Diagnostics, Medical Devices, eQMS, eDMS, London”

All applicants must prove they are legally entitled to work in the UK. CY Partners is acting as an Employment Business / Agency in relation to this vacancy.