The QA Manager is responsible for managing the company’s Quality Management System in accordance with Company, International Standards and Customer requirements.
The QA Manager will also be the champion for driving a culture of quality throughout the company as well as defining and implementing a strategy to evolve the QMS to meet the changing needs of the business.
Key Tasks / Accountabilities
- QMS direction, planning and leadership – ensure that the QMS meets the current needs of the business and that we plan for and manage QMS change; bringing along stakeholders as the QMS evolves with business needs, markets and applications
- ISO 9001 - Maintenance of a QMS that achieves ISO 9001:2015 certification and compliance with the Low voltage Directive and Medical Devices Directive, as well as compliance to any additional relevant standards, directives and regulations identified as a requirement for the business
- Representation - act in the role of Management Representative, represent QA in project teams and take part in Risk Management and Phase / Gate reviews. Work with all departments to ensure that all QMS activities are implemented effectively and are operating to meet the needs of the business.
- Processes – management of the Quality process, e.g. change control, CAPA, document control, supplier evaluation, etc. Lead on Post-Market Surveillance.
- Reporting – produce reports as required on the effectiveness of the QMS and other quality data to inform the management of the business
- Audits – management of internal, external and supplier audits including recruiting and training of internal auditors. Liaise and co-operate with Certification and Notified Bodies and work with external RA consultants as required.
- Documentation - management of the Q-Pulse electronic QMS package, including using the system to generate metrics and trends relating to non-conformances and complaints
- Training – be responsible for all quality training throughout the business including inductions, QMS, Q-Pulse, quality processes, standards, regulations, etc.
- Management – structure a small team to deliver the quality service function to the business and be responsible for the management and development of that team. Develop and implement quality management strategies and plans to support, contribute to, and integrate within, the organisation's annual business plan and long-term strategy.
- Standards – be responsible for ensuring that any changes in standards or regulations are identified and communicated to allow time for implementation
- Experience of Q-Pulse and/or CogniDox digital document management systems.
- Experience of using paper based, controlled approvals process.
Education & Training
The successful candidate is likely to have a Quality related CPD log showing formal training and development activities related to ISO standards and European Directives
- Stakeholder engagement – to be successful in this role, you need a strong ability to effectively engage and influence stakeholders (i.e. operations, projects, engineering, management, etc). The ability to take a transformational approach rather than an autocratic one is what will set you apart from the field.
- Team building – you will be responsible for building, managing and developing a small (3) but effective team to support the Owlstone business. The composition of this team and the roles that they cover will be driven by your vision of how quality will work within the business and how it will support the business functions.
- Change Management – Driving transformational change as the company grows and evolves, the ability to engage and drive with the changes and scale / evolve the QMS accordingly in line with the business, is essential.
- Document control – Experience of using a formal, version-controlled digital document management system in a QA context is essential.
Experience / Knowledge
- Highly organised, pro-active and self-motivated team leader with experience in leading an SME through ISO 9001:2015 transition or initial certification.
- Experience designing and introducing quality systems meeting the requirements of ISO 13485 or 21 CFR 820 is desirable
- Knowledge of MDD 93/42/EEC, MDR 2017/745, FDA approvals
Knowledge of the Machinery Directive and other directives / regulations
MS Office applications - intermediate / advanced level (particularly Excel)
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 by clicking on the 'Apply for Role' link below.