Owlstone Medical has developed a breathalyzer for the early detection of cancer, inflammatory and infectious disease. Our mission is to save 100,000 lives and $1.5B in healthcare costs. We need to add an experienced QA Manager to our team to help us achieve it.
About the Job:
The QA Manager is responsible for managing the companies Quality Management System in accordance with Company, International Standards and Customer requirements.
Responsibilities will include:
- Upgrading of the existing QMS from ISO 9001:2008 to ISO 9001:2015
- Implementation of ISO 13485:2016and 21 CFR 820 in a new medical devices/instrumentation company
- Act in the role of Management Representative as required by ISO 13485:2016
- Maintenance of the QMS within the business to achieve ongoing compliance all relevant standards identified as a requirement for the business.
- Leading QA projects from idea to implementation and compliance, and managing validation/risk analysis activities.
- The planning and implementation of supplier and internal quality audits.
- Provide training to employees on the Quality System compliance requirements.
- Developing and implementing quality management strategies and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation’s annual business plan and long term strategy
- Liaise and co-operate with Certification and Notified Bodies as required.
- Working with the RA team to ensure that the QMS meets all regulatory requirements
- Working with all departments to ensure that all QMS activities are implemented effectively and are operating to meet the needs of the business.
- Plan and manage departmental activities in accordance with agreed budgets and timescales
- Report as necessary on changes in standards that could impact on the performance or requirements for the QMS.
- Manage staff according to company standards (appraisals, training, development, etc)
- Manage departmental performance against agreed targets and budgets, and within policies and standards
- Reporting on the performance and effectiveness of the Quality System to the companies Top Management
- To be responsible for the management of the change control process
The successful candidate will have/be:
- You must be highly organised, methodical with excellent attention to detail, possess excellent communication, influencing, QMS and PC skills.
- A degree in Engineering, Sciences or Technology and/or a Professional Quality Assurance qualification is essential for this role
- Minimum of 5 years’ experience working within Quality Assurance role in a medical device company
- Familiarity with other regulatory standards required by the business i.e. EN 61010, ISO 14971 etc.
- Has the ability to work under pressure (individually and as part of a team), to effectively manage the workload to meet challenging deadlines whilst maintaining quality standards within a dynamic commercial environment.
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 telltale markers of disease, which our microchip chemical sensor technology is able to detect. They 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 it drops 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, Defence and Security.
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 share options and your work will have a clear impact on patients’ lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone is 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 Reveal email address