Description
Quality Engineer - Contract
Key: Medical Device/Pharma Quality Engineering, Validation, Regulatory
Duration: Initially 6 months
Rate: Negotiable per day
Location: South Wales
Our exclusive client urgently requires the services of additional Contract Quality Engineers to provide support for design/development and manufacture of medical devices including electrosurgical instruments. 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.
The ideal candidate will have:
* A Degree (or equivalent) in an engineering or related discipline.
* Experience in a Quality Engineering or Quality Assurance role in a class II or class III medical devices environment taking products from definition to production.
* Working knowledge of ISO 13485, FDA 21 CFR part 820, IEC 60601, BS EN 14971, ISO 10993, ISO 11137.
* Understanding of process validation, process control and statistics cleanroom manufacture, electronics manufacturing techniques desirable.
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.
Please apply either by sending your CV direct to (see below) OR via the link below, Thanks
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