ODx Innovations – Document Controller

ODx Ltd is a UK based R & D Partner collaborating with leading global providers of sophisticated products for life science research and clinical diagnostics markets. Developing technologies to transform the performance of antibiotic sensitivity testing laboratory and point-of-care products,

With a mission to bring cost-effective, accurate and speedy technology solutions to address the growing problem of bacterial resistance to antibiotics, ODx are developing technologies which will be relevant in several medical environments, will dramatically increase the speed of results for patients and will enable faster and more accurate prescription of the most appropriate drugs

Document Controller

Working within a dynamic and innovative development environment, you will be a key member of the Quality team and responsible for implementing, co-ordinating and maintaining the company’s Document Control systems, processes and procedures. Supporting product development for ODx’s POC medical device, which are currently being tested in the UK and US centres, you will undertake day-to-day management of the quality system to ensure compliance against ISO 13485 requirements.

You will have an exciting and challenging role, your duties and responsibilities including;

  • Operational management of document control and ensuring all associated documentation is maintained to meet company and regulatory requirements
  • Coordinate, implement, and maintain the company’s Document Control processes
  • Control the numbering, sorting, filing, storing and retrieval of both electronic and hard copy documents.
  • Strictly follow established procedures and policies needed to meet the demands of document control in a regulated medical device company
  • Review and provide advice on SOPs, working instructions and quality agreements for suppliers
  • Document archiving including reconciliation of paper and electronic files as required and prior to archiving
  • Manage change control documentation and support the quality team to resolve quality issues
  • Assist with and support all internal and external audits
  • You will have proven experience leading and managing document control within a highly regulated environment and be well versed in ensuring documentation is maintained to meet company, client and industry / regulatory requirements. You will be a strong influencer, a good communicator and be able to engage and work with a variety of internal and external stakeholder groups. Previous experience within an ISO 9001 or 13485 environment is essential, previous experience within a Life Sciences or Medical Device organisation would be a distinct advantage.

    In addition to working within a highly dynamic organisation supporting lifesaving product development, you will be rewarded with a highly competitive salary and package.

    Eden Scott is working as recruitment partner with ODx and any direct or referral applications will be forwarded to them for inclusion in the recruitment campaign – any candidate submissions from alternative sources will not be considered. For an informal discussion or for further details on this outstanding opportunity, please call Ian Grant.