Description
Quality Engineer/Validation Engineer - Contract
Key: Quality Engineer role covering concept to manufacture (including QC and validation and regulatory work)
Location: Monmouthshire
Duration: Initially 6 months
Rate: Negotiable
We've partnered with a rapidly expanding, innovative Medical Device organisation that urgently requires the services of an experienced Quality Engineers/Validation Engineers to join their expanding team on a contract basis for initially 6 months.
The purpose of this role is to provide support to quality assurance for design/development and manufacture of medical devices. Specifically, for carrying out quality control processes and the generation and/or review and approval of associated records and ensuring compliance to the requirements of ISO 13485:2016 and US FDA quality system regulation.
Examples of processes and/or record review include:
o Sub-assembly and finished product manufacturing records
o Inspection
o Nonconformance
o Product labelling
o Equipment calibration and maintenance
o Controlled environments monitoring
o Training records
The role is essential to ensuring products are designed, developed and manufactured to a high quality and to supporting compliance to regulatory requirements. The role requires close and proactive working with design/development engineers and technicians, production technicians, purchasing and materials control personnel, the manufacturing and quality assurance managers, and other personnel as necessary.
For further information, please send an up-to-date CV to (see below) or apply via the link.
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