Contract Quality Engineer – South Wales

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

The Job:

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.

Responsibilities:

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.

Qualifications:

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.

Hannah Milward - Recruitment Consultant at CK ScienceHow to apply:

Apply online:

For more information or to apply for this Contract Quality Engineer role please contact Hannah Milward on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH24543 in all correspondence.

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