Quality Manager Medical Devices - Warwickshire

13 Apr 2018
26 Apr 2018
Job Type
Contract Type
Alex Tosney is recruiting for a Quality Manager to join a leading medical device company based in Warwickshire. This is an opportunity to join an exciting and dynamic company who are at the forefront of medical science. This is a fantastic opportunity to join an innovative company on a permanent basis who are set to positively affect patients lives.

The primary responsibility for the Quality Manager will be to design and implement the QMS structure covering a multi-skilled development team.
The responsibilities of the Quality Manager will be:
- To ensure that there is a QMS in place that satisfies the requirements of the relevant quality standards
- To strategically create and implement the QMS Audit Plan
- To maintain a process of regular audit QMS in line with the QMS Audit Plan and report on status of effectiveness to company management
- To implement improvements where necessary in collaboration with relevant stakeholders
- Support of External Audit, ensuring audit priorities are clearly communicated and the internal resources are made available
- Implementation of QMS Audit against Audit Plan
- Identification of action priorities based on Gap Analysis from Internal Audit.
- Definition, development and qualification of QMS tools to meet short-term and strategic business requirements.
- Setup of Quality Plan for company Products
- Implementation of Supplier Audit against Audit Plan to assure adequacy of the Product Supply Chain
- To provide quality assurance support of design and development process
- Management of Document Administration Process
- To ensure that a comprehensive set of KPI's are defined, to measure performance of the company against agreed targets.

The Quality Manager should have the following skills and experience:
- Extensive experience working in product development and delivery
- Experience in working with PEMS or equivalent high-integrity software-intensive Experience and capability in root cause analysis, leading issue investigation and resolution, documentation and testing
- Experience of working with requirements management systems, document management systems and issue management systems
- Experience in definition and qualification of tools in support of the QMS
- Familiarity with regulatory standards i.e. MDD (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820, 21 CFR 807, 21 CFR 11
- Ability to identify strategic and operational issues and develop plans to address
- Ability to lead; demonstrating assertiveness, team building and management skills

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC41793 in all correspondence.