Technical Co-ordinator (Medical Devices)
Our Client is the world’s leading inspection, verification, testing and certification company; they are recognised as the global benchmark for quality and integrity. With more than 95,000 employees they operate a network of more than 2,400 offices and laboratories around the world. We now welcome applications for the role of Technical Co-ordinator (Medical Devices).
The successful candidate will be primarily responsible for supporting the medical devices team in the production of audit proposals, planning of audits and answering of technical queries to ensure KPI’s on turnaround of documentation and financial targets both globally and in the UK are met., this will include:
*Supporting affiliates in their medical device activities to ensure future growth of medical device certification worldwide.
*To review client vigilance reports, monitor trends in client reporting, and to ensure appropriate action is taken in a timely fashion.
*To ensure affiliates are made aware of vigilance issues for their clients, and that audits are planned accordingly to address vigilance concerns.
*To operate as a technical resource within the medical team and ensure that technical queries are adequately answered or forwarded to the appropriate technical expert or manager.
*Undertake the day to day management and co-ordination of the technical documentation review process. This includes liaison with clients, contractors and external agencies.
*Review and approve the Technical File Matrices.
*Perform an initial review of audit packs to ensure that administrative and regulatory errors are removed prior to technical pack review.
*Review medical device questionnaires and prepare proposals and PWS (Proposal Worksheets) promptly to avoid customer delays.
*To approve PWS documents to maximise revenue generation.
*Co-ordinate the technical documentation review process undertaken by contractors to ensure timely delivery of outputs. To assist in the planning of audits, ensuring appropriate allocation of audit resources to ensure auditor time is fully utilised
The role requires a person with significant technical experience, either via device clinical use or design / manufacture. Significant office or administrative experience including databases and spread sheets. Able to demonstrate attention to detail and team working ability. Able to organise own work load and day to day priorities, understand new technical issues relating to medical devices quickly, work under pressure with excellent PC literacy. A tertiary technical qualification relevant to medical devices to meet GHTF educational requirements – e.g. electronics, nursing, biology, pharmacy, materials
The role offers a highly competitive salary, annual bonus, health cover after 1 year and a pension.
Please apply in complete confidence with your current CV