£30000 - £35000 per annum + benefits
Opportunity for an experienced document controller / quality administrator to join a well-financed, innovative medical device company.
Why you should apply
This is your chance to join a fast-moving, innovative company, with significant backing, in a high-growth and high-value market - but at an early enough stage that you can genuinely steer the product.
This is an ideal opportunity for an experienced document controller / quality administrator with a point to prove. The employer has a diverse and talented senior team who will afford you plenty of autonomy and coach you to fulfil your potential.
About the company
The business is ambitious and aims to be a globally recognised scientific innovator, developing working FDA/CE tools for large multi-national partners and providing new solutions for diagnostics and treatment to improve human health.
Rather than replicating the existing medical device product development models, the company is innovating the field with agile development techniques and cutting-edge science to bring rapid evolution of medical device products to the market.
About the document controller / quality administrator position
Responsible for coordinating QMS activities, supporting the preparation and upload of documents and data into the QMS and ensuring that document control processes are followed and are compliant with ISO 13485.
In addition, the role will also include supporting with broader general administration tasks that include minute taking, maintaining project action logs, and supporting the development of the company Sharepoint. Further duties will include: -
- Manage and coordinate document control via the electronic QMS and Sharepoint
- Contribute to the drafting of documentation, manage the review and approval of documents, including SOPs, WIs, and forms within the QMS
- Preparing documents, data and files for upload into the QMS
- Provide administrative support to users of the QMS, assisting with configurations using the internal platform.
- Generate reports from the QMS to provide meaningful monitoring and measurement data.
- Support internal audits as an internal auditor, along with management of corrective actions
- Support the delivery of the non-conformance and CAPA management system in the business
- Champion compliance to all applicable standards, regulations and internal procedures by proactively interpreting quality and regulatory requirements and implementing solutions
- Support with general office management such as organising travel for staff and holiday tracking
- Minute taking and maintenance of the project action log
To apply for the document controller / quality administrator position, you will need: -
- Extensive document controller / quality administrtion experience, ideally gained within the medical device sector to include ISO 13485
- eQMS experience
- Superb organisation skills, with the ability to thrive under pressure
- Excellent general IT skills, including sound knowledge of Teams, Sharepoint, and MS Project.
The document controller / quality administrator will receive a salary of around £30,000 - £35,000 plus benefits.
If you are interested in the document controller / quality administrator position, please apply today!
By applying you're giving consent for the Sigma Recruitment agency in Cardiff, to contact you regarding this job and other vacancies we're recruiting for.
Job Skills: document controller, QMS administrator, medical devices, QMS, [email protected]