Hannah Milward at CK Science is recruiting for a Contract Quality Engineer to join an international medical devices organisation at their site in South Wales
As a Contract Quality Engineer you will join an international medical devices organisation, with a reputation for developing innovative and cutting edge products within this dynamic industry, This is an excellent opportunity for an experienced Contract Quality Engineer to enhance and develop their career.
As a Contract Quality Engineer you will be responsible for the following:
- Support Design teams, providing directed quality engineering and regulatory expertise in support of component design realisation.
- Ensuring solutions are compliant, in the most efficient manner with ISO 134585, FDA 21 CFR Part 820, MDD 93-42-EEC
- Liaison with vendors for co-ordination of component qualification activities, review and approval of quality related documentation via ORACLE PLM or other systems.
- Initial and surveillance assessment audits of vendors quality and manufacturing systems.
- Assist in the development of appropriate component verification and validation strategies including test method validation for products, processes and components.
- Ensuring vendors generate process validation plans, review and approval of validation documentation as part of component submission documentation.
- Provide ad hoc Quality Engineering support in other areas such as: other projects, operations problem analysis, process analysis and process and vendor improvements.
- To adhere to the Rules and Regulations of the company as laid out in the Staff Handbook.
To be considered for this Contract Quality Engineer position you will have the following qualifications and skills:
- An HNC or equivalent in a relevant discipline
- Experience in vendor auditing
- Experience working with precision mechanical small scale components
- Experience producing high standard documentation within regulated industry.
For more information or to apply for this Contract Quality Engineer role please contact Hannah Milward on 0114 283 9956 or email firstname.lastname@example.org. Please quote reference SH24543 in all correspondence.