Description
Quality Engineer - Contract
Key: Medical Device/Pharma Quality Engineering, Quality Assurance, Regulatory, Product Introduction
Duration: Initially 6 months
Rate: Negotiable per day
Location: South Wales
Our rapidly expanding, excluisve client requires the services of additional experienced 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 with 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.
* Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
* There is an emphasis on candidates having experience of supporting new product development teams in a quality role ie supporting them through the regulatory Pathway from the definition of a project to release to market primarily in the US or Europe. This will involve review and generation of technical file documentation and ensuring that teams are operating to the quality system and regulatory requirements.
* Must have sufficient knowledge of the following regulations to act as the subject matter expert within the development team:- ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971.
* Working knowledge of ISO 10993, IEC 60601 ISO 11137 desirable.
* An understanding of process validation, process control and statistics cleanroom manufacturer, 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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