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Quality Engineer - Design Assurance

Posted a day ago

  • Luton, Bedfordshire
  • Any
  • External
  • Expires In 3 months
Quality Engineer - Design Assurance
Location: Bedford, Hybrid
Contract: Full time, permanent
Salary: £35,000 - £40,000 + Benefits
Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They are a joint venture and one of their brands are recognised all over the world as providing accurate home pregnancy and fertility monitoring tests.
Due to internal promotion, they are looking for a Quality Engineer - Design Assurance to join their Quality team on a permanent, full-time contract.
The role will be based at their Innovation Centre in Bedford, UK with option for Hybrid Working.
The Quality Engineer’s focus is supporting compliance of our client’s Innovation projects to all required standards and regulations supporting compliance of Quality activities relating to Design Assurance including Documentation and Device Design Change Control across areas of the business including Concept Innovation, New Product Introductions (NPI), Transfer to Manufacturing and Software as a Medical Device. The role holder will also perform general Quality Assurance duties as required in support of fulfilment of the Quality Objectives.
The role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies with ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US F...