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)