We are an award-winning medical device company that specialises in the design and manufacture of innovative textile-based implantable medical devices.
- Assist the Technical Quality Team in providing technical support on issues which arise relating to quality of product or quality aspects of manufacturing. This will include, but is not limited to, subjects such as clean room monitoring, sterility, changes in processes or processing aids, raw material changes, internal incidents or complaints.
- Support the Technical Quality Team in any Quality Investigations relating to microbiology or other non-conformances.
- Support shelf life studies including packaging, product stability and biocompatibility.
- Support Technical Services with the introduction of new equipment and processes ensuring they are validated in accordance with applicable regulations.
- Design and perform method and equipment validations.
- Update procedures and other documents using a change control system.
- Review of quality documents including design documents, risk management files and clinical evaluations.
- Perform risk assessments where required.
- Undertake any other duties as may be requested by the Technical Quality Team.
Essential Experience, Knowledge and Qualifications
- Scientific or engineering degree.
- Relevant technical experience preferably in a Medical Device company.
- Good technical writing ability and the ability to manage and prioritise your own workload.
Desirable Experience, Knowledge and Qualifications
- Experience of Quality Systems in a medical device company.
- Knowledge of ISO 13485.
Essential Skills and Behaviours
- Excellent interpersonal skills, including the ability to work as part of a team.
- Able to lead by example and act as a role model.
- Good organisation skills and attention to detail.
- A can do attitude with the ability to take initiative and work to deadlines.
- Self-motivated with personal commitment to the role and to providing a high quality service.
- Send a copy of your CV and a covering letter of application to firstname.lastname@example.org.