Quality Assurance Assistant

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Quality Assurance Assistant

  • Location

    Cambridge, Cambridgeshire

  • Sector:


  • Job Type:


  • Salary:

    £25000 - £30000 per annum + Pension, healthcare & bonus

  • Contact:

    Vicki Clague

  • Contact email:


  • Job Ref:


  • Published:

    about 3 years ago

  • Expiry Date:


  • Startdate:


Job Purpose

Our client is looking for a Quality Assurance Assistant to join their cutting edge, digital health business in Cambridge. The Quality Assurance Assistant will be working directly with the Senior Quality Assurance & Regulatory Manager in a variety of exciting and diverse projects. Due to the nature of this work you will not only be able to pay particular attention to detail but also have a methodical and analytical approach to each task you undertake. You will have excellent observation skills as you will be required to monitor and observe working practices to ensure standards are being met. This is a fantastic opportunity for a Quality Assurance Assistant to join an innovative, growing business.

This WILL be with Quality Assurance of documents and not of the product.

Main Responsibilities

  • Managing department reports including company quality objectives and communicating these company-wide
  • Managing the timely reporting of non-conformities and CAPA Management
  • Managing review of new and existing suppliers
  • Preparation of quality assurance documentation
  • Assisting with risk management activities
  • Assisting in managing project plans, design and development files and medical device files
  • Assisting in internal and external audits
  • Assisting with completion of technical and regulatory documentation

Qualifications, Knowledge and Experience

  • Bachelor's degree in Science related subject (Biology/ Genetics/ Bioinformatics/ Software preferred) or equivalent work experience
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Experience of working with ISO 13485 quality management systems
  • Experience of dealing with non-conformities and CAPA management
  • Friendly, approachable and builds positive personal and organisational relationships
  • Self-motivated and results-driven, problem-solver
  • Enthusiastic, hardworking, well organised and able to prioritise
  • Able to work with others, and willing to contribute to team
  • Professional appearance and able to produce high standards of work

Desirable Knowledge and Experience

  • Training within risk management and/or company audits
  • Working knowledge of JIRA, Confluence

  • Experience of CE marking of software
  • Experience of Medical Device files
  • Understanding of In-vitro diagnostic device regulations (IVDD, IVDR, FDA, NMPA)


  • Pension
  • Parking
  • Commission
  • Healthcare

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