Document Controller – IVD / Medical Devices
12 month contract
Based in London
£ Highly competitive salary
Do you have experience supporting document control and quality system administration within a medical devices, diagnostics, or biotechnology organisation?
Would you like to join the quality team at a ground-breaking medical diagnostics organisation, at a really exciting stage of product development?
My client is 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 Document Controller – IVD / Medical Devices, who will play a key role in supporting the Quality Management System (QMS) through high-volume document control, records review and system administration activities.
This role is well suited to someone who is highly organised, detail-driven and motivated by structured, process-led work in a regulated environment.
Key Responsibilities of the Document Controller – IVD / Medical Devices will include;
* Manage controlled documentation within the QMS, ensuring compliance with company procedures and regulatory requirements.
* Perform high-volume review, upload and maintenance of quality records within the electronic QMS (Greenlight Guru).
* Review and maintain supplier quality records to ensure completeness and compliance.
* Support equipment records review, upkeep and control within the quality system.
* Archive and organise quality documentation in line with internal procedures and regulatory expectations.
* Ensure documents are accurately maintained, up to date and readily accessible.
* Support the QA team and wider business by ensuring documentation is prepared, reviewed, approved and stored within agreed timelines.
* Identify documentation gaps or inconsistencies and take appropriate action to resolve them.
* Maintain strong document control discipline in line with ISO 13485 and applicable medical device regulations.
Please note: this role does not involve internal audits or CAPA ownership.
To be considered for the Document Controller – IVD / Medical Devices vacancy, you’ll need the following skills and experience;
* Prior Document Control or Quality System administration experience, ideally within medical devices, diagnostics, or biotechnology.
* Experience working with an electronic Document Management System (eDMS) and/or electronic QMS (eQMS).
* A good working understanding of medical device regulations such as ISO 13485 and 21 CFR Part 820.
* Strong organisational skills with the ability to manage high volumes of documentation accurately.
* High attention to detail and a methodical approach to record review and data integrity.
* Self-motivated and able to work independently on repetitive, process-driven tasks.
* Confident IT skills, including Microsoft Office and quality systems.
* Good communication skills to support effective collaboration with internal stakeholders.
* A degree (or equivalent working experience) in a scientific or technical discipline such as Biology, Chemistry, Biotechnology, or a related field. In the absence of a degree, A-Levels or equivalent experience will be considered.
For further information, please apply online or contact Dan Younger at CY Partners for further information.
Key Words:
“Document Controller, Document Control, Quality Systems, QMS, ISO 13485, 21 CFR 820, Medical Devices, IVD, Diagnostics, eQMS, eDMS, Greenlight Guru, Supplier Records, Equipment Records, QA Support, London”
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners is acting as an Employment Business / Agency in relation to this vacancy.