Quality Engineer (Post Market)
The Purpose of the Post:
Owlstone is seeking a Post Market Quality Engineer to support current medical device product lines for sale within Europe (and in the future the U.S), in particular leading the customer complaints, vigilance and post market processes.
Key Responsibilities and Duties:
Key Responsibilities and Duties:
- Ensure compliance to regulatory requirements including, as appropriate the Medical Devices Directive and ISO 9001
- Ensure that all customer complaints are logged in the relevant company systems in a timely manner in-line with company procedures
- Ensure that customer reported complaints are investigated adequately and that root cause findings and corrective action results are communicated to appropriate internal stakeholders in a timely manner
- Prepare reports for MDV and MDR in EU and US and provide support for any communications with relevant regulators as required
- Assist with the investigation, risk assessment and resolution of product quality issues
- Maintain the product Technical Files, including updating risk the Risk Management File, Essential Requirements Checklist and Clinical Evaluation following product quality issue investigations or design, process or regulatory changes
- Provide support for updates to Instructions for Use and Labels as required following product quality issue investigations or design, process or regulatory changes
- Authorship of the Post Market Clinical Follow Up Plan and coordination of the work to implement this
- Support maintenance of existing products following design, process or supplier changes
- Coordinate the validation of the effectiveness of proposed post market solutions and their implementation in the field with other departments as required and update the Technical File as appropriate
- Report on KPI relating to post market activities and customer complaints
- Be part of the Internal Audit team and support audits of Suppliers
- Assist with external audits to achieve and/or maintain ISO accreditation
- 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
- Proven experience in quality engineering related activities, preferably in a medical device environment
- Proven track record of conformance to regulatory requirements including as appropriate Medical Devices Directive and ISO 9001:2015
- Knowledge of Post Market Surveillance, Customer Complaint, Vigilance and Reporting Requirements
- Experience with creation and/or updating Device Technical Files, including Risk Management, in response to market feedback
- Ability to demonstrate a self-motivated and highly organised approach to work
- Experience of 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.
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/3b2c8c08a5574a40b5ed86b17e8d4ffb