|Job Title:||Quality Engineer|
|Contact Name:||Julie McEwan|
|Job Published:||September 03, 2019 09:04|
As Quality Engineer, you will play a pivotal role within the wider project teams, assisting with quality considerations throughout new product realisation and the life cycle of legacy devices. Working to lead best practice in the specifications and design requirements and verification of the company’s product portfolio. You will also manage key Quality Management System activities such as internal and external audits, the investigation of complaints, change control, CAPA’s and third-party supplier management to ensure compliance.
Collaborating with multi-disciplinary departments the successful candidate will be responsible for risk management activities ensuring compliance with all regulations, including ISO 13485 and FDA 21CFR part 820. Your duties will include review and approval of device history files and assisting in the writing of verification and validation protocols and plans.
A global point of care diagnostics and clinical decision support software manufacturer and a trusted NHS supplier. Striving to make diagnostic based care simpler, more efficient and more accessible, they are expanding across all continents from subsidiaries to employees. Focusing on better health, better experiences and better outcomes they aim to improve relationships between patients, ease the pressure on healthcare budgets and promote healthier lives.
My client is looking for someone who has already gained experience within a commercial quality environment, ideally within IVD, although other types of medical devices will also be considered. As a dynamic and innovative company, working to provide next generation products, they are looking for motivated and enthusiastic individuals. Someone who has excellent communication and project management skills and an ability to work on multiple projects simultaneously. Previous experience within a ISO 13485 regulated environment is essential, in addition to medical device post launch exposure across at least two products.
A life sciences undergraduate degree and proven understanding of electromechanical devices, both hardware and software, would be highly advantageous.
My client is offering a competitive salary and benefit package, alongside the opportunity to work at the cutting edge of new diagnostics, having a positive impact not only on patient outcomes but also for the healthcare professionals that rely on these devices.
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