Quality Engineer

Quality Engineer
  • £35,000 - £45,000 per Annum
  • Permanent
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK SG8 6ED
Job Ref: J2162615
Sector: Engineering
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 08 November 2021
We have an exciting opportunity for a quality engineer to join an ambitious, well-funded point-of-care diagnostics business based in Cambridge.

With the product coming closer to market launch, they are looking for a proactive quality professional to join the team to help with ensuring quality requirements are incorporated into the product from concept, design, and development to manufacture.

As a Quality Engineer you will be focusing on product risk management, design verification testing activities to identify requirements and the creation and maintenance of the product Design History File/ Technical Design Dossier. Along with those, some of your main responsibilities will include:

  • Lead product risk management activities according to ISO 14971
  • Guide and provide oversight of hazard analyses, FMEAs, FTAs
  • Prepare and maintain Risk Management Plans, hazard traceability matrices and Risk Management Reports
  • Fulfil the active role of Quality representative at Design Authority/ Design Review meetings
  • Create and maintain the Design History File/ Technical Design Dossier for the product and its variants
  • Assess technical and design changes and ensure that these are suitably documented, and the regulatory authority notified where necessary
  • Ensure that customer and regulatory requirements are maintained throughout product design and development activities

As the ideal candidate you will have experience in the medical device industries, participating in IVD design and development activities and understanding of the IVD regulatory pathways. You will have a degree in engineering or similar discipline and understand standards such as ISO 13485, 14971, 62304, QSR, 60601. You will have experience providing quality oversight in Design Review meetings as part of a Design Authority and the ability to apply core quality tools and methodologies such as 8D, DMAIC.

08/12/2021 16:23:59
GBP 35000.00 45000.00 Annum

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