Head of Quality, Medical Devices
Salary: CIRCA £70,000 (DOE could pay more/ less)
Benefits: 5% - 8% pension contribution, upto 19% performance bonus, 33 days holiday total
Our Client, a major Medical Devices company who are experiencing significant growth at this time; are looking to appoint an experienced Head of Quality (HOQ). This is an amazing company to work for, they have a modern culture onsite and the facility is state of the art.
The HOQ is responsible for assuring the quality of Client's products (manufactured outside of Asia) and for its services; This will be achieved through the deployment of efficient quality management systems (QMS) necessary to support Client's activities including as legal manufacturer of medical devices and WDA holder for pharmaceuticals too.
- The role involves working and advising stakeholders at all levels throughout the business on topics relating to compliance and product quality.
- Particular focus will be needed on supplier management; the support of new product introductions and change control activities.
- Leading the development, improvement and implementation of quality management systems and processes. Ensure the continuous improvement; standardisation; improved efficiency and global alignment of the Clients quality management systems. Ensuring that all relevant QMS certifications are maintained.
- The implementation and efficient utilisation of an electronic QMS across multiple sites.
- Maintaining an awareness and ensuring compliance with all relevant QA requirements in all markets (e.g. changes necessary for compliance with EU MDR).
- Ensuring that post-market quality issues are handled and reported according to customer and regulatory expectations.
- Ensure appropriate participation and support of the quality assurance aspects of new product introduction.
- Ensure that an effective supplier management process is established (oversight / monitoring / agreements) Ensure that effective change control processes are implemented and operated
- Provide advice on quality (and regulatory) requirements to key stakeholders as appropriate.
- Manage staff (develop and support) to achieve their responsibilities and objectives (Quality Assurance Manager and Quality Assurance Specialists).
- Ensure the Clients business activities receive adequate support from the quality assurance function.
- Ensure efficient and timely delivery of quality improvement related projects.
- Selection, monitor and management of quality consultants
- Deputise for RA/QA Director
- Will hold a Degree in a relevant, Scientific discipline
- Significant management experience in a Medical Devices setting (ideally will have some Pharmaceutical knowledge with this).
- Strong central QMS implementation and coaching experience with supplier management experience too.