LOCATION OF WORK: A mixture of onsite work in Cambridge and remote working
A Cambridge based business that specialises in the medical device and drug delivery sector requires a Senior Quality Engineer to join its quality engineering department.
In this role you will have opportunity work on a wide range of exciting medical device and drug delivery projects for a range of different clients.
Internally you will be working with project teams (consisting of Engineers and Project Managers) to ensure devices are developed in line with internal QMS policies and procedures. This will mean providing guidance to different project teams and carrying out the required design assurance task work.
The role also offers you the opportunity to work directly with the businesses clients to ensure their QMS policies and procedures are met. This will mean working with clients and delivering the relevant quality project documentation.
For this role you must demonstrate a good understanding of medical devices quality standards, with regulatory standards experience being highly desirable.
As this role offers you the chance to work with lots of different people (both internally and externally) you should be someone who has excellent communication skills and enjoys working with different individuals.
Someone who is a Quality Engineer and a ‘people person’ will flourish in this role.
– Ensuring compliance to internal and external QMS policies
– Providing guidance to project teams in implementing the QMS
– Enabling the application of the QMS within projects. This includes:
* Reviewing and approving project documentation
* Ensuring traceability of goods on projects
* Collaborating with Project Administrators to maintain project documentation register, and documentation and preparation of elements of DHF/Technical Files
* Supporting Team QA during audits
* Opportunity to develop and improve internal QMS and be involved in the implementation of new tools that impact the delivery of projects.
- 3+ years’ experience in Medical Devices or Drug Delivery projects
- Experience of project quality management
- Demonstrable experience in quality assurance
- Experience of creating and managing elements of a Design History File / Technical File
- Knowledge of ISO 13485, FDA QSR and Medical Device Directives
- HND in quality or relevant degree, e.g. in engineering or science
- Excellent communication skills
- Comfortable working with internal colleagues and external clients