Owlstone Medical’s mission is to save 100,000 lives and save health care providers $1.5B. With several major projects underway to develop disease screening and diagnosis based on detection of metabolic products in breath, we are looking for an experienced instrument operator to join our clinical laboratory team based in Cambridge, UK.
The Purpose of the Post:
Owlstone is seeking a Quality Engineer to lead the ongoing support of our current range of CE marked medical devices and assist with the delivery of future medical product development projects for deployment in Europe and the U.S.
Key Responsibilities and Duties:
- Ensure product conformance to regulatory requirements including as appropriate the Medical Devices Directive, In Vitro Diagnostics Directive, ISO 13485, ISO 14971, IEC 62304, ISO 62366 and 21 CFR part 820.
- Author of key requirements, specifications, risk analysis and traceability documentation.
- Provide support and direction on all quality activities necessary for the project team to achieve all key design control deliverables.
- Assist in meeting the requirements of post market surveillance and vigilance in line with the Medical Devices Directive.
- Manage ongoing updates to current products and maintain the product technical files.
- Manage and lead design reviews.
- Complete and maintain Essential Requirements Checklists.
- Assist with external audits to achieve and maintain ISO accreditation.
- Ensure product compliance with the Quality Management System.
- Report of progress to management and escalate issues and risks pro-actively through appropriate channels.
Essential Experience and skills
- Educated to degree level.
- Proven experience in medical product development and quality engineering related activities in a medical device or in vitro diagnostic environment.
- Proven track record of conformance to regulatory requirements including as appropriate Medical Devices Directive, In Vitro Diagnostics Directive, ISO 13485, ISO 14971, IEC 62304, ISO 62366 and 21 CFR part 820.
- Ability to demonstrate a self-motivated and highly organised approach to work.
- Experience working with minimal supervision in a fast paced, multiple disciplinary environment.
- Good written and verbal communication skills.
- Ability to liaise with all key functions of the business.
Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.
Every time you breathe out there are hundreds of chemicals on your breath – some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.
Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% – unfortunately there are still far too many people detected at late stage.
The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.
We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.
To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to email.