The Purpose of the Post:
Owlstone is seeking a Quality Engineer to join the QA team to provide support for current medical device product lines for sale within the UK and Europe, in particular leading the customer complaints, vigilance and post market processes, while supporting the QMS throughout the company.
Key Responsibilities and Duties:
- Ensure compliance to regulatory requirements including, as appropriate, the Medical Devices Directive and ISO 9001
- Ensure that all customer complaints logged in the relevant company systems are reviewed in a timely manner, in-line with company procedures and legal requirements
- Work with the manufacturing engineers and technical experts to ensure that all complaints are investigated adequately with root cause findings
- identified and corrective actions suitably closed out
- Review the Risk Management File during resolution of product quality issues, and update as required
- Provide support for updates to Instructions for Use and Labels as required following product quality issue investigations or design, process or regulatory changes
- Coordinate any validation work required following changes to products
- Ensure the Essential Requirements Checklist is up to date at all times
- Report on KPI relating to post market activities and customer complaints
- When required, assist with preparing reports for MDV in UK/EU
- Provide support for controlled document reviews, including proof reading and converting documents to new templates
- Be part of the Internal Audit team and support audits of Suppliers
- Assist with external audits to achieve and/or maintain ISO certification
- Support the QMS as required by the QA Manager
- Provide a positive example and actively promote compliance to all standards
Essential Experience and skills:
- Educated to degree level or equivalent
- Proven experience working in a manufacturing environment
- Proven track record of conformance to regulatory requirements including as appropriate Medical Devices Directive and ISO 9001:2015
- Ability to liaise with all key functions of the business and coordinate activities cross functionally
- Ability to demonstrate a self-motivated and highly organised approach to work
- Excellent attention to detail
- Experience of working with minimal supervision in a fast-paced environment
- Good written and verbal communication skills
Desirable Experience and skills:
- Proven experience working as part of a QA team
- Knowledge of Post Market Surveillance, Customer Complaint, Vigilance and Reporting Requirements
- Experience with creation and/or updating Device Technical Files, including Risk Management and Essential Requirements checklists, in response to market feedback or product changes
- Experience of updating Clinical Evaluation Reports in response to customer feedback and post market product changes
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.
Owlstone is an equal opportunity employer and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.
Due to the nature of our business, all employment is subject to satisfactory references being obtained and attainment of a Baseline Personnel Security Standard (BPSS) check.
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 https://app.smartsheet.com/b/form/4f3df91e662344eb988672e3f2086703